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BEMA-GMBH & CO. KG

Germany · Emmingen Baden-Wurttemberg

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

20listed device types

Class I 18Class II 2Class III 0

plus 22 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States22 registration records, 1 510(k), 0 PMA

Brazil4 confirmed, 1 excluded

Manufacturer names merged into this page: BEMA-GMBH & CO. KG · BEMA GMBH & CO. KG

FDA 510(k) clearances by year

12011 · K102921

FDA listed device types

showing 8 of 20

Nipper, Malleus 1Forceps, Wire Closure, Ent, Non-Sterile 1Holder, Needle, Gastroenterologic 1Retractor, Self-Retaining 1Forceps, General & Plastic Surgery 1Scissors, Nasal 1Hook, Surgical, General & Plastic Surgery 1Punch, Ent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K102921	ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES	2011-12-20
BR	10368410058	FAMILIA DE MATERIAL ARTICULADO PARA VÍDEO-CIRURGIA	Class I
BR	10314800063	INSTRUMENTAIS NÃO ARTICULADOS PERFUROCORTANTES PARA ARTROSCOPIA	Class I
BR	10314800062	INSTRUMENTAIS ARTICULADOS NÃO CORTANTES PARA ARTROSCOPIA	Class I

BEMA-GMBH & CO. KG

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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