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BOWA - ELECTRONIC GMBH & CO. KG

Germany · Gomaringen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

12listed device types

Class I 1Class II 11Class III 0

plus 24 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

11 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

11valid device licences

Class I 1Class II 10

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

24active ARTG entries

Class I 5IIb 19

HKHong KongMDACS

5valid listings

Class II 2Class III 3

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

11active registrations

Class 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 States24 registration records, 2 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: BOWA-ELECTRONIC GMBH & CO. KG · BOWA - ELECTRONIC GMBH & CO. KG · BOWA-electronic GmbH & Co. KG

FDA 510(k) clearances by year

12018 · K173877

12020 · K193591

FDA listed device types

showing 8 of 12

Electrosurgical, Cutting & Coagulation & Accessories 1Stimulator, Nerve, Battery-Powered 1Nasopharyngoscope (Flexible Or Rigid) 1System, Surgical, Computer Controlled Instrument 1Endoscope, Ac-Powered And Accessories 1Forceps, Biopsy, Electric 1Laparoscope, Gynecologic (And Accessories) 1Electrode, Electrosurgical, Active, Urological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193591	ARC 400	2020-04-02
US	K173877	BOWA Neutral Electrodes	2018-02-15
BR	81532939002	CABOS E ADAPTADORES ELETROCIRURGICOS	Class II
BR	81532939003	Bolsa Coletora	Class II
BR	80224390265	CABO DO PACIENTE BOWA PARA ELETRODO NEUTRO	Class II
SA	ME0000003623SFDAA00010	Monopolar Cable	—