Data / Medical devices / Device, Heat-Sealing

Device, Heat-Sealing (KSD): 17 FDA-registered makers in 10 countries

Name: FDA-registered makers of Device, Heat-Sealing
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 10 countries are registered with the FDA to make Device, Heat-Sealing (product code KSD, Class 1, 21 CFR 864.9750). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 9, 1982, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: KSD
Device class: 1
Regulation: 864.9750
Medical specialty: Hematology

Makers by country

Country	Makers
United States	4
Sweden	2
China	2
France	2
Germany	2
South Korea	1
Italy	1
India	1
Malaysia	1
Belgium	1

Makers of Device, Heat-Sealing

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.

Maker	Location	Role	Source
AB Elektronik-Konstruktion Innovation (Abelko)	Lulea, Sweden	Manufacturer	api.fda.gov
Centron Corporation	Anyang-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
Changsha Yingtai Instrument Co., Ltd	changsha city Hunan, China	Manufacturer	api.fda.gov
Conroy Medical AB	UPPLANDS VASBY Stockholm, Sweden	Manufacturer	api.fda.gov
Delcon SRL	Grassobbio Bergamo, Italy	Contract manufacturer, Manufacturer	api.fda.gov
Fenwal, Inc.	Lake Zurich, IL, United States	Complaint file establishment, Specification developer	api.fda.gov
Guangxi Ehall Medical Technology Co.,ltd	Nanning Guangxi, China	Exporter to the US, Manufacturer	api.fda.gov
Itas G Pharma	Guwahati Assam, India	Manufacturer	api.fda.gov
Itl Asia Pacific Sdn Bhd	Batu Gajah Perak, Malaysia	Manufacturer	api.fda.gov
Maco Pharma	MOUVAUX Hauts-de-France, France	Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer	api.fda.gov
Macoproductions S.A.S.	TOURCOING Nord, France	Foreign private label distributor, Manufacturer	api.fda.gov
Moeller Medical GMBH	FULDA Hesse, Germany	Manufacturer	api.fda.gov
OriGen Biomedical, Inc.	Austin, TX, United States	Complaint file establishment, Manufacturer	api.fda.gov
Sarstedt AG & Co. KG	NUMBRECHT North Rhine-Westphalia, Germany	Manufacturer	api.fda.gov
Terumo BCT Europe N.V.	Leuven Vlaams Brabant, Belgium	Contract manufacturer	api.fda.gov
Terumo BCT, Inc..	Lakewood, CO, United States	Manufacturer	api.fda.gov
Vante, Inc.	Tucson, AZ, United States	Contract manufacturer, Manufacturer	api.fda.gov

Updated April 9, 1982. 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.