ERBE Elektromedizin GmbH

FDA Device Registration & Listing · Rangendingen Baden-Wurttemberg, DE · Registration 3009762450

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
3009762450
FEI Number
3009762450
Entity Name
ERBE Elektromedizin GmbH
City/State/Country
Rangendingen Baden-Wurttemberg, DE
Establishment Address
Rudolf-Diesel-Str. 29, Rangendingen Baden-Wurttemberg 72414, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ERBE ELEKTROMEDIZIN GMBH (Owner Number: 8010173)
Owner / Operator Contact Address
WALDHOERNLESTRASSE 17, --, TUEBINGEN, DE-NOTA 72072, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243451
PMA Number
N/A

All Registered Proprietary Names

HybridAPC probe ERBEJET® 2 System ERBE Hybrid Knife FiAPC Plus ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe ERBECRYO® 2 Cart ERBECRYO® 2 1-pedal footswitch ERBECRYO® 2, Cryosurgical unit Flexible gas hose Gas bottle adapter Exhaust gas hose Flexible Cryoprobe Extension cable Switching valve with 2 adapters MOVIVA Hybrid Ablation Probe ERBEJET 2 System ERBEJET 2 two pedal footswitch HybridTherm System: Electrosurgical Unit VIO 3, Cryosurgical Unit ERBECRYO 2, HybridTherm probes, accessories Erbe APCapplicators HybridAPC Probe ERBEJET® 2 System ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe FiAPC plus probes

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FQH Lavage, Jet General Hospital Class 2 880.5475 2025-07-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-18
FQH Lavage, Jet General Hospital Class 2 880.5475 2023-07-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-07-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-09-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-11-21
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2026-04-28
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2020-01-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-01-07
FQH Lavage, Jet General Hospital Class 2 880.5475 2026-01-07
FQH Lavage, Jet General Hospital Class 2 880.5475 2007-12-06
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2024-08-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-08-22
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2024-08-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-04-05
FQH Lavage, Jet General Hospital Class 2 880.5475 2015-10-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-10-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-03-25

Official Correspondent

No official correspondent registered.

US Agent Details

John Tartal Business: ERBE USA, INC. Email: John.Tartal@erbegroup.com Phone: (770) 9554400

Related Public Records

Same Entity

ERBE ELEKTROMEDIZIN GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9610614 ERBE ELEKTROMEDIZIN GMBH TUEBINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K213616 Becton, Dickinson and Company BD Surgiphor Antimicrobial Irrigation System 2022-03-23
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
Z-0037-05 N/A 2
NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009762450. Last updated year: 2026. Please use registration number 3009762450 when referencing this establishment in official correspondence.
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