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Data / Medical devices / Enteral Syringes With Enteral Specific Connectors

Enteral Syringes With Enteral Specific Connectors (PNR): 29 FDA-registered makers in 10 countries

29 establishments in 10 countries are registered with the FDA to make Enteral Syringes With Enteral Specific Connectors (product code PNR, Class 2, 21 CFR 876.5980). 21 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on July 1, 2026, and lists 1 recall event (1 Class I). FDA data exported November 3, 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
PNR
Device class
2
Regulation
876.5980
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
China12
United States8
Mexico2
Singapore1
United Kingdom1
Italy1
Rwanda1
Cambodia1
Canada1
Thailand1

Makers of Enteral Syringes With Enteral Specific Connectors

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
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer4April 30, 2019000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer3December 19, 2024000api.fda.gov
CMT Health Pte. Ltd.Singapore, SingaporeExporter to the US, Specification developer2April 8, 2026000api.fda.gov
Cardinal HealthNorfolk, NE, United StatesManufacturer2December 19, 2024000api.fda.gov
Cardinal HealthDeland, FL, United StatesManufacturer2December 19, 2024000api.fda.gov
Gbuk Group LimitedSelby North Yorkshire, United KingdomExporter to the US, Specification developer2August 6, 2019000api.fda.gov
Medela LLCMchenry, IL, United StatesManufacturer, Specification developer2February 15, 2017000api.fda.gov
Pentaferte Italia S.R.L.CAMPLI Teramo, ItalyManufacturer2February 28, 2022000api.fda.gov
Shantou Wealy Medical Instrument Co., Ltd.SHANTOU Guangdong, ChinaManufacturer2August 27, 2021000api.fda.gov
American Health PackagingColumbus, OH, United StatesComplaint file establishment, Reprocessor1August 6, 2019000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaManufacturer1March 30, 2018000api.fda.gov
Avent S. de R.L. de C.V.TIJUANA Baja California, MexicoManufacturer1June 17, 2016000api.fda.gov
Cardinal Health (Kenmex Medical Specialties)TIJUANA Baja California, MexicoManufacturer1May 12, 2016000api.fda.gov
Intl. Medical IndustriesPompano Beach, FL, United StatesManufacturer1October 6, 2017000api.fda.gov
Jiangsu Caina Medical Co., LtdJiangyin Jiangsu, ChinaContract manufacturer, Manufacturer1August 6, 2019000api.fda.gov
Jiangsu Kangbao Medical Equipment Co., LtdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer1November 9, 2018000api.fda.gov
Jiangsu Micsafe Medical Technology Co., LtdYancheng Jiangsu, ChinaManufacturer1October 11, 2018000api.fda.gov
Ningbo Tianyi Medical Appliance CO., Ltd.Ningbo Zhejiang, ChinaContract manufacturer, Contract sterilizer, Manufacturer1April 28, 2021000api.fda.gov
Shandong Ande Healthcare Apparatus Co., Ltd.Zibo Shandong, ChinaManufacturer1September 12, 2020000api.fda.gov
TKMD Rwanda LtdRwamagana, lburasirazuba Eastern Province, RwandaManufacturer1August 17, 2023000api.fda.gov
VR Medical Technology Co., Ltd.KUNSHAN Jiangsu, ChinaManufacturer1September 22, 2016000api.fda.gov
Aena Medical (jiangsu) Co.,ltd.Jiangyin City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Amsino Medical (shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Anhui Tiankang Medical Technology Co., Ltd.Tianchang Anhui, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Camedical Technology (cambodia) Co., Ltd.Samraong Takeo, CambodiaContract manufacturer0000api.fda.gov
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.Chengdu Sichuan, ChinaContract manufacturer0000api.fda.gov
CLAYENS Crystal Lake, LLCCrystal Lake, IL, United StatesContract manufacturer0000api.fda.gov
Medxl IncPointe-Claire Quebec, CanadaContract manufacturer0000api.fda.gov
Tianyi Medical (thailand) Co., Ltd.PLUAKDAENG DISTRICT Rayong, ThailandContract manufacturer, Contract sterilizer0000api.fda.gov

Updated July 1, 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.