Data / Medical devices / Germany / Sarstedt AG & Co. KG

Sarstedt AG & Co. KG: FDA-registered device maker in NUMBRECHT North Rhine-Westphalia, Germany, 4 510(k) clearances

Name: Sarstedt AG & Co. KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sarstedt AG & Co. KG is registered with the FDA (registration 9617475) in NUMBRECHT North Rhine-Westphalia, Germany. It lists 23 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 25, 2005. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Sarstedt AG & Co. KG

FDA registration number: 9617475
FEI number: 3002808075
Address: Sarstedtstrasse 1, NUMBRECHT North Rhine-Westphalia, Germany, 51588
Owner or operator: SARSTEDT AG & CO. KG (8010078)
Roles: Exporter to the US, Manufacturer
First device listed: November 18, 1977
Registered through: 2026
Brand names listed: Cool Transport Container, General Centrifuges LC, Monovettes, Monovette Needles, Micro needles, Multifly Needles, Adapters, Monovettes, Monovette Needles, Multifly Needles, Adapters, S-Monovette ACD-A, SAHARA-III MAXITHERM 115V, SAHARA-III basic model 115V, SAHARA-TSC 115V and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Blood/Plasma Collection Device For Dna Testing	PJE	2	Manufacturer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Sterile	KDT	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile	NNL	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Manufacturer	accessdata.fda.gov
Device, Automated Sedimentation Rate	GKB	1	Manufacturer	accessdata.fda.gov
Device, Heat-Sealing	KSD	1	Manufacturer	accessdata.fda.gov
Device, Warming. Blood And Plasma	KZL	2	Manufacturer	accessdata.fda.gov
Dish, Tissue Culture	KIZ	1	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Flask, Tissue Culture	KJA	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Micro Pipette	JRC	1	Manufacturer	accessdata.fda.gov
Mixer, Blood Tube	GLE	1	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Manufacturer	accessdata.fda.gov
Test, Erythrocyte Sedimentation Rate	JPH	1	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Exporter to the US	accessdata.fda.gov
Tube, Collection, Capillary Blood	GIO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tube, Sedimentation Rate	GHC	1	Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 25, 2005	K051019	SAFETY NEEDLE	JKA	Substantially Equivalent	Sarstedt, Inc.	accessdata.fda.gov
September 12, 2003	K032150	SAFETY-MULTIFLY	FPA	Substantially Equivalent	Sarstedt, Inc.	accessdata.fda.gov
September 12, 2003	K031359	S-MONOVETTE EDTA K2-GEL	PJE	Substantially Equivalent	Sarstedt, Inc.	accessdata.fda.gov
April 14, 2003	K024237	URINE MONOVETTE BORIC ACID	JSM	Substantially Equivalent	Sarstedt, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 25, 2005. 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.