Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006038700

FEI Number

3006038700

Entity Name

Tomed GmbH

City/State/Country

Koeln North Rhine-Westphalia, DE

Establishment Address

Im Rapsfeld 57, Koeln North Rhine-Westphalia 50933, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tomed GmbH (Owner Number: 9088701)

Owner / Operator Contact Address

Im Rapsfeld 57, --, Köln, DE-NOTA 50933, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121761

PMA Number

N/A

All Registered Proprietary Names

SOMNOGUARD SomnoGuard® AP SomnoGuard® 2 SomnoGuard® AP PRO SomnoGuard® AP 2 SomnoGuard SPX SomnoGuard SP Pro SomnoGuard SP Soft

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2006-09-22
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2012-11-14

Official Correspondent

Aylin Duesterhoeft

US Agent Details

Scott Whitcomb Business: 1st. Line Medical, Inc. Email: swhitcomb@1stlinemedical.com Phone: (603) 8667208

Related Public Records

Same Entity

Tomed GmbH

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
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006038700. Last updated year: 2026. Please use registration number 3006038700 when referencing this establishment in official correspondence.