Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006165521

FEI Number

3006165521

Entity Name

MICROCOAT BIOTECHNOLOGIE GMBH

City/State/Country

Bernried Bavaria, DE

Establishment Address

Am Neuland 3, Bernried Bavaria 82347, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Microcoat Biotechnologie GmbH (Owner Number: 10082962)

Owner / Operator Contact Address

Am Neuland 3, Bernried, DE-BY 82347, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MeMed BV TM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QPS	Immunoassay For Host Biomarkers Of Infection	Microbiology	Class 2	866.3215	2021-10-18

Official Correspondent

Yvonne Kerwitz

US Agent Details

Adrian Keene Business: NAMSA Email: usagentservices@namsa.com Phone: (419) 6664855

Related Public Records

Same Entity

Microcoat Biotechnologie GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006165521. Last updated year: 2026. Please use registration number 3006165521 when referencing this establishment in official correspondence.