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TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.

Taiwan · Taipei

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Australia — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 7Class II 0Class III 0

plus 7 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

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

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States7 registration records, 9 510(k), 0 PMA, 4 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. · TEH LIN PROSTHETIC & ORTHOPAEDIC INC.

FDA 510(k) clearances by year

12002

22003 · K022696

42004 · K042012

22005 · K051118

FDA listed device types

Joint, Shoulder, External Limb Component 1Unit, Wrist, External Limb Component, Mechanical 1Component, External, Limb, Ankle/Foot 1Hand, External Limb Component, Powered 1Joint, Knee, External Limb Component 1Hand, External Limb Component, Mechanical 1Hook, External Limb Component, Mechanical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K051118	MODEL TL-360 POWER SCOOTER	2005-05-31
US	K051116	MODEL TL-560 POWER SCOOTER	2005-05-31
US	K042012	TEH LIN POWER SCOOTER, MODEL TL-822	2004-09-24
BR	80314090036	FAMÍLIA DE COMPONENTES E ARTIGOS PARA CONFECÇÃO DE PRÓTESES EXTERNAS D	Class I
BR	80314090033	FAMÍLIA DE COMPONENTES E ARTIGOS PARA CONFECÇÃO DE PRÓTESES EXTERNAS D	Class I
BR	80314090038	FAMÍLIA DE ATADURA GESSADA MOLDÁVEL - TEH LIN	Class I

TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.

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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