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ERBE ELEKTROMEDIZIN GMBH

Germany · Tuebingen

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 0Class II 9Class III 0

plus 49 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

10 including historic records

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 2Class III 1

27 including historic records

TWTaiwanTFDA

23valid device licences

Class I 1Class II 22

SGSingaporeHSA SMDR

8device registrations

CLASS B 3CLASS C 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

48active ARTG entries

Class I 6IIa 5IIb 37

HKHong KongMDACS

25valid listings

Class II 1Class III 24

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

13active registrations

Class 2a 2Class 2b 11

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States49 registration records, 16 510(k), 0 PMA, 4 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada3 confirmed, 2 excluded

Manufacturer names merged into this page: ERBE ELEKTROMEDIZIN GMBH · ERBE Elektromedizin GmbH

FDA 510(k) clearances by year

11994

12016

32019

12020

22023

22024

42025

22026

FDA listed device types

showing 8 of 9

Electrosurgical, Cutting & Coagulation & Accessories 1Resectoscope, Working Element 1Endoscopic Injection Needle, Gastroenterology-Urology 1Unit, Cryosurgical, Accessories 1Endoscopic Irrigation/Suction System 1Electrode, Electrosurgical 1Electrode, Electrosurgical, Active, Urological 1Resectoscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261806	ERBECRYO 2 Cryosurgical Unit and Accessories	2026-06-09
US	K253230	ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe	2026-04-22
US	K253915	MOVIVA® Hybrid Ablation Probe	2025-12-18
BR	81612419001	Unidade de Aspiração de Fumaça	Class II
BR	81612410000	ADAPTADOR DE APLICADOR APC PARA APC 2 COM TOMADA APC	Class I
SA	ME0000001015SFDAA00002	Monopolar Cable	—
SA	ME0000001015SFDAA00003	Bipolar Connecting Cable	—
CA	15188	ERBE ELECTROSURGICAL GENERATORS	Class III
CA	87059	BICISION	Class II
CA	91696	ERBELIFT HAND PUMP AND FLEXIBLE PROBE	Class II