Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009642126

FEI Number

3009642126

Entity Name

SANNER GMBH

City/State/Country

Bensheim Hesse, DE

Establishment Address

Bertha-Benz-Strasse 5, Bensheim Hesse 64625, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sanner GmbH (Owner Number: 10078530)

Owner / Operator Contact Address

Bertha-Benz-Strasse 5, Bensheim, DE-HE 64625, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vivatmo Oxycaps me, Vivatmo Oxycaps pro, Vivatmo Oxycaps Level O

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2024-03-14

Official Correspondent

Antje Dr. Caelers

US Agent Details

Terrance Ashburn Business: Gilero - A Sanner Group Company Email: tashburn@gilero.com Phone: (984) 2276423

Related Public Records

Same Entity

Sanner GmbH

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

View Entity Profile →

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3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009642126. Last updated year: 2026. Please use registration number 3009642126 when referencing this establishment in official correspondence.