Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617475

FEI Number

3002808075

Entity Name

SARSTEDT AG & CO. KG

City/State/Country

NUMBRECHT North Rhine-Westphalia, DE

Establishment Address

Sarstedtstrasse 1, NUMBRECHT North Rhine-Westphalia 51588, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SARSTEDT AG & CO. KG (Owner Number: 8010078)

Owner / Operator Contact Address

SARSTEDTSTR. 1, --, NUMBRECHT, DE-NW 51588, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAHARA-TSC 115V Tourniquet Urine container, Urin-Monovettes, Salivettes, tubes, Screw caps for container, Feaces container, Inserts General Centrifuges LC Urine Container, Urine Monovettes, Faeces Container, Tubes, Screw caps, CryoPure

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	1996-03-18
KZL	Device, Warming. Blood And Plasma	Hematology	Class 2	864.9205	2007-12-07
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2007-12-07
GHC	Tube, Sedimentation Rate	Hematology	Class 1	864.6700	1997-10-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-12-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-07
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	Class 2	862.1675	2007-12-07
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2000-02-18
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2001-07-09
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	1977-11-18
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2016-08-25
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1996-04-01
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	2000-02-04
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	1996-03-18
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	1998-11-25
JPH	Test, Erythrocyte Sedimentation Rate	Hematology	Class 1	864.6700	1997-10-20
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2008-06-19
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2007-12-11
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	1998-11-25

Official Correspondent

JOCHEN HOFFMANN

US Agent Details

Susan Smith Business: SARSTEDT, INC. Email: susan.smith@sarstedt.com Phone: (828) 4654000

Related Public Records

Same Entity

SARSTEDT AG & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2242368	SARSTEDT, INC.	NEWTON, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617475. Last updated year: 2026. Please use registration number 9617475 when referencing this establishment in official correspondence.