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Data / Medical devices / Container, Specimen Mailer And Storage, Non-Sterile

Container, Specimen Mailer And Storage, Non-Sterile (NNK): 144 FDA-registered makers in 23 countries

144 establishments in 23 countries are registered with the FDA to make Container, Specimen Mailer And Storage, Non-Sterile (product code NNK, Class 1, 21 CFR 864.3250). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
NNK
Device class
1
Regulation
864.3250
Medical specialty
Pathology

Makers by country

CountryMakers
United States48
China45
Canada9
Germany7
Vietnam7
United Kingdom4
Taiwan4
Netherlands2
South Korea2
Austria2
India2
Sweden1
Switzerland1
Italy1
Myanmar1
Denmark1
Malaysia1
Cambodia1
Thailand1
Ireland1
Slovakia1
Australia1
Turkey1

Makers of Container, Specimen Mailer And Storage, Non-Sterile

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aero-Med LLCEast Hartford, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ahlstrom Germany GMBHBarenstein Saxony, GermanyManufacturer0000api.fda.gov
Alom Technologies CorporationFremont, CA, United StatesContract manufacturer0000api.fda.gov
ALOM Technologies CorporationIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Advance Dx, Inc.Scottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Agendia IncIrvine, CA, United StatesManufacturer0000api.fda.gov
Agendia NVAmsterdam Noord-Holland, NetherlandsSpecification developer0000api.fda.gov
Alltrista Plastics LLCReedsville, PA, United StatesManufacturer0000api.fda.gov
American Laboratory Products CompanySalem, NH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Bach Viet PlasticHo Chi Minh city, VietnamContract manufacturer0000api.fda.gov
Biosys Laboratories, Inc.S Pasadena, CA, United StatesSpecification developer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Capitainer ABSolna Stockholm, SwedenComplaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer0000api.fda.gov
Cellpath LtdNEWTOWN Powys, United KingdomManufacturer, Repackager or relabeler0000api.fda.gov
Changzhou DSB Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Chematics, Inc.North Webster, IN, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
CITOTEST Labware Manufacturing CO., LTD.Haimen Jiangsu, ChinaManufacturer0000api.fda.gov
Citotest Scientific Co.,ltd.Nanjing Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Color Diagnostics, LLCSouth San Francisco, CA, United StatesSpecification developer0000api.fda.gov
Covaris, LLCWoburn, MA, United StatesManufacturer0000api.fda.gov
CalibreScientific US, Inc.Vancouver, WA, United StatesManufacturer0000api.fda.gov
Dalian Rongbang Medical Healthy Devices Co LtdDalian Liaoning, ChinaManufacturer0000api.fda.gov
DBS System S.AGland Vaud, SwitzerlandExporter to the US, Manufacturer0000api.fda.gov
Diapath S.P.A.Martinengo Bergamo, ItalyManufacturer0000api.fda.gov
Diatrust Medical Co., Ltd.Nanjing City Jiangsu, ChinaManufacturer0000api.fda.gov
Dieu Thuong Joint Stock CompanyTam Phuoc Ward Dong Nai, VietnamManufacturer0000api.fda.gov
Dignity Care NetworkRetford Nottinghamshire, United KingdomSpecification developer0000api.fda.gov
Dna Genotek, Inc.Ottawa Ontario, CanadaManufacturer0000api.fda.gov
Double Packing (myanmar) Co LtdYangon, MyanmarContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Dxterity Diagnostics Inc.Torrance, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dyad Enterprise LLCKing of Prussia, PA, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Dongguan Hong De Medical Plastic Products Co. Ltd.Dongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan SafeSecure Plastics Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Epitope Diagnostics, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Focus Tendence CorporationTaichung, TaiwanExporter to the US, Manufacturer0000api.fda.gov
GD Group Co., Ltd.Eumseong Chungbuk, South KoreaManufacturer0000api.fda.gov
Gene By GeneHouston, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Genetrack Biolabs Inc.Vancouver British Columbia, CanadaContract manufacturer, Repackager or relabeler0000api.fda.gov
Geschuetzte Werkstaetten Integrative Betriebe Salzburg GMBHSt. Margareten Salzburg, AustriaContract manufacturer0000api.fda.gov
GLX Medical Devices Company LimitedBien Hoa Dong Nai, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
GP Medical Devices A/SHolstebro Midtjylland, DenmarkManufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Haimen Shengbang Laboratory Equipment Co., LtdHaimen Jiangsu, ChinaManufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
HBH Biotechnology LimitedYantai Shandong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Heng Rong (xiamen) Plastic Products Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Hochuen Medical Sdn. Bhd.SENAI Johor, MalaysiaContract manufacturer0000api.fda.gov
Home Access Health Corp.Hoffman Est, IL, United StatesManufacturer0000api.fda.gov
Huachenyang(shenzhen)technology Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Hochuen Medical Technology Co.,Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Huakang Packaging Technology Co., Ltd.Prey Nob Preah Sihanouk, CambodiaManufacturer0000api.fda.gov
Immundiagnostik AGBensheim Hesse, GermanyManufacturer0000api.fda.gov
Imperial Surgical Ltd.Lachine Quebec, CanadaManufacturer0000api.fda.gov
Intelligent Fingerprinting LimitedCambridge Cambridgeshire, United KingdomManufacturer0000api.fda.gov
J Summit Co., Ltd.Chomthong Krung Thep Maha Nakhon, ThailandContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Kangjian Medical Apparatus Co., Ltd.JIANGYAN Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jinan Babio Biotechnology Co.,ltd.Jinan City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jinhua Jingdi Medical Supplies Co.,ltdJinhua Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangsu Huida Medical Instruments Co., LtdYancheng Jiangsu, ChinaManufacturer0000api.fda.gov
Kova International IncGarden Grove, CA, United StatesManufacturer0000api.fda.gov
L-D Tool & Die Division Of Madix EngineeringOttawa Ontario, CanadaContract manufacturer0000api.fda.gov
La Party Corporation Vietnam Co., LtdBau Bang district Binh Duong, VietnamExporter to the US, Manufacturer0000api.fda.gov
Labcon, North AmericaPetaluma, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Labone, Inc.Lenexa, KS, United StatesSpecification developer0000api.fda.gov
Les Plastiques MDJ Inc.Saint-Hubert Quebec, CanadaContract manufacturer0000api.fda.gov
LiquimedlockMarkham Ontario, CanadaManufacturer0000api.fda.gov
Long Sheng Plastics Tech. Co., LtdDouliu Yunlin, TaiwanContract manufacturer0000api.fda.gov
Lotus Packaging Trading Service Production Joint Stock Company.Ho Chi Minh City, VietnamContract manufacturer0000api.fda.gov
Lucid Diagnostics, Inc.Foxborough, MA, United StatesSpecification developer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Med Auxil Analysis Aids E.K.Seesen Lower Saxony, GermanyManufacturer0000api.fda.gov
Medical Chemical CorporationTorrance, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Medite Medical GMBHBurgdorf Lower Saxony, GermanyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MML Diagnostics Packaging, Inc.Troutdale, OR, United StatesContract manufacturer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Ningbo Chibanda Imp &exp Co, LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ningbo Yingmed Medical Instruments Co.,ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Novogenia GMBHEugendorf Salzburg, AustriaManufacturer0000api.fda.gov
Pathright Medical,,inc.Orem, UT, United StatesManufacturer0000api.fda.gov
Pathway Medtech, LLC.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Peak 5 Packaging LLCOmaha, NE, United StatesContract manufacturer0000api.fda.gov
Pretium Canada Packaging ULCETOBICOKE Ontario, CanadaManufacturer, Repackager or relabeler0000api.fda.gov
Primed Instruments, Inc.MISSISSAUGA Ontario, CanadaManufacturer0000api.fda.gov
Privapath Diagnostics LtdDublin 11 Dublin(County), IrelandManufacturer0000api.fda.gov
Quicksilver Scientific, Inc.Louisville, CO, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Quanzhou Enrich Hygienic Products Co., Ltd.Quanzhou Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Researchdx,inc.Irvine, CA, United StatesContract manufacturer0000api.fda.gov
RR DonnelleyHouston, TX, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Revvity Health Sciences, Inc.Greenville, SC, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Safesecure Medical Packaging Company LimitedHai Phong City, VietnamContract manufacturer0000api.fda.gov
Sakura Finetek Europe B.V.Alphen aan den Rijn Zuid-Holland, NetherlandsExporter to the US, Manufacturer0000api.fda.gov
Sakura Finetek U.s.a., Inc.Torrance, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Sarstedt AG & Co. KGNUMBRECHT North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Sarstedt, Inc.Newton, NC, United StatesManufacturer0000api.fda.gov
Schebo Biotech AGGIESSEN Hesse, GermanyForeign private label distributor, Manufacturer0000api.fda.gov
SG BioScience, INCDongdaemun-gu Seoul, South KoreaManufacturer0000api.fda.gov
Shandong Haidike Medical Products Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Huayue Packaging Products Co., Ltd.Fengxian District, Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Leyi Plastic Products Co LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Youding International Trade Co., Ltd.Shanghai, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Shengzyi Enterprise Co., LtdKaohsiung city, TaiwanManufacturer0000api.fda.gov
Shenzhen Bairunheng Technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Simport Scientific Inc.BELOEIL Quebec, CanadaManufacturer, Specification developer0000api.fda.gov
Spot Health Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Stirilab S.R.O.Ruzomberok Zilinsky, SlovakiaManufacturer0000api.fda.gov
Suzhou Labyrinth Biotech Co., LtdSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Suzhou Pipi Medical Products Co.,ltdSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
SVP Packing Industry Pvt LtdMUMBAI Maharashtra, IndiaContract manufacturer0000api.fda.gov
Sage Product Development, Inc.Foxborough, MA, United StatesContract manufacturer0000api.fda.gov
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen SafeSecure Medical Infection Control Tech Co., LtdShenzhen City Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Sun Diagnostics, LLCNew Gloucester, ME, United StatesSpecification developer0000api.fda.gov
Sun Nuclear CorporationNorfolk, VA, United StatesManufacturer, Specification developer0000api.fda.gov
Ta Ting Plastic (hai Duong) Co.,ltdCam Giang Commune Hai Phong, VietnamManufacturer0000api.fda.gov
Taizhou Rich Medical Products Co., Ltd.TAIZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Tasso IncSeattle, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Telimmune, LLC.North Webster, IN, United StatesManufacturer0000api.fda.gov
Tissue Protective Products Co., Ltdtianmen Hubei, ChinaManufacturer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, United StatesSpecification developer0000api.fda.gov
Trajan Scientific Australia Pty LtdRingwood Victoria, AustraliaComplaint file establishment, Manufacturer0000api.fda.gov
Therapak, LLCOakwood, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Therapak, LLCClaremont, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Typenex Medical, LLCChicago, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Unipack Equipment Co., LtdKaohsiung City, TaiwanManufacturer0000api.fda.gov
University Medical DevicesOmaha, NE, United StatesSpecification developer0000api.fda.gov
Virchow Medical, Inc.San Diego, CA, United StatesSpecification developer0000api.fda.gov
Vonco Products, LLCTrevor, WI, United StatesManufacturer0000api.fda.gov
WESTFIELD MEDICAL LTD (Part of Sterimed)Radstock Somerset, United KingdomManufacturer0000api.fda.gov
Willow Tree Solutions, LLCEast Hartford, CT, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Xiamen Chuangkai Industry & Trade Co. Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen JPL Industry & Trade Co. Ltd.Xiang An Area, XiaMen Fujian, ChinaManufacturer0000api.fda.gov
Yancheng Jingwei Chemicals Co., LtdYancheng Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yantai Bagmart Packaging Co LtdYantai Shandong, ChinaManufacturer0000api.fda.gov
Yeni Biyoteknoloji Anonim SirketiBALCOVA Izmir, TurkeyManufacturer0000api.fda.gov
Zhejiang Gene Science Co., Ltdshaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Runlab Technology Co., Ltd.Taizhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Gongdong Medical Technology Co., LtdTAIZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Sorfa Life Science Research Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.