Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242368

FEI Number

2242368

Entity Name

SARSTEDT, INC.

City/State/Country

NEWTON, NC, US

Establishment Address

1025 Saint James Church Rd, NEWTON, NC 28658, US

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

Urine Container, Urine Monovettes, Faeces Container, Tubes, Screw caps, CryoPure General Centrifuges LC Tourniquet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	1977-11-18
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2008-06-19
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	1998-11-25
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2007-12-11
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2000-02-18
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	1996-04-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9617475	SARSTEDT AG & CO. KG	NUMBRECHT North Rhine-Westphalia, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2242368. Last updated year: 2026. Please use registration number 2242368 when referencing this establishment in official correspondence.