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Bauerfeind GmbH & Co.

Germany · Zeulenroda-Triebes

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 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

14listed device types

Class I 13Class II 1Class III 0

plus 16 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 16

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

16valid device licences

Class I 16

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

41active ARTG entries

Class I 41

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

7active registrations

Class 1 7

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 States16 registration records, 3 510(k), 0 PMA, 1 excluded

Brazil16 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: BAUERFEIND AG · BAUERFEIND AG

FDA 510(k) clearances by year

11986 · K860826

12011 · K111662

12013 · K123921

FDA listed device types

showing 8 of 14

Orthosis, Corrective Shoe 1Orthosis, Limb Brace 1Orthosis, Lumbar 1Aid, Transfer 1Sling, Arm 1Device, Prosthesis Alignment 1Joint, Ankle, External Brace 1Support, Arm 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123921	BODYTRONIC 200	2013-04-26
US	K111662	VENOTRAIN CURAFLOW	2011-10-04
US	K860826	VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE	1986-06-18
BR	81396120004	Linha Loc para membros inferiores	Class I
BR	81396120005	Linha Loc para membros superiores	Class I
BR	81396120016	Imobilizadores para Membros Inferiores	Class I
SA	ME0000012408SFDAA00001	Veno Train Micro	—
SA	ME0000012408SFDAA00002	Veno Train Pure	—
CA	90345	BODYTRONIC 200	Class II

Bauerfeind GmbH & Co.

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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