Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003332988

FEI Number

3003332988

Entity Name

RIENSCH & HELD GMBH & CO. KG

City/State/Country

Hamburg, DE

Establishment Address

Hans-Duncker-Str. 1, Hamburg 21035, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Riensch & Held GmbH & Co. KG (Owner Number: 10050512)

Owner / Operator Contact Address

Hans-Duncker-Str. 1, Hamburg, DE-HH 21035, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MicroGard II Filter Kit MicroGard II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2015-11-26

Official Correspondent

Thorgen Rubel

US Agent Details

Cally Kothmann Business: Jaeger Medical America Email: GMB-RDX-Regulatory@jaegerrdx.com Phone: (714) 6858094

Related Public Records

Same Entity

Riensch & Held GmbH & Co. KG

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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3007289408	Medline Canada	Guelph Ontario, CA
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003332988. Last updated year: 2026. Please use registration number 3003332988 when referencing this establishment in official correspondence.