SOMI MEDICAL GMBH

FDA Device Registration & Listing · Pforzheim Baden-Wurttemberg, DE · Registration 3027339887

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027339887
FEI Number
3027339887
Entity Name
SOMI MEDICAL GMBH
City/State/Country
Pforzheim Baden-Wurttemberg, DE
Establishment Address
Karlsruher Strasse 24, Pforzheim Baden-Wurttemberg 75179, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SOMI medical GmbH (Owner Number: 10088034)
Owner / Operator Contact Address
Karlsruher Strasse 24, Pforzheim, DE-BW 75179, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2025-09-26
DZI Drill, Bone, Powered Dental Class 2 872.4120 2025-09-26
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2025-09-26
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-09-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-17

Official Correspondent

Rainer Johe

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

SOMI medical 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
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027339887. Last updated year: 2026. Please use registration number 3027339887 when referencing this establishment in official correspondence.
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