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OPPO MEDICAL INC.

✓ Record-verifiedregistrations found in 5 marketsEU SRN US-MF-000005202

This company has registrations in European Union, United States, United Kingdom, Brazil, Australia — 5 overseas markets. EU UDI-DI records ≥298, the first 300 verified individually. 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

≥298UDI-DI device records

Class I 298

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

23listed device types

Class I 23Class II 0Class III 0

plus 46 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 18

BRBrazilANVISA

2registered devices

Class I 2

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

pendingnot queried

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.

European Union3,678 raw hits, 2 excluded, 298 confirmed. Large result set — only the first 300 verified

United States46 registration records, 0 510(k), 0 PMA

United Kingdom18 confirmed, 1 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: OPPO MEDICAL CORP · OPPO MEDICAL, INC. · OPPO MEDICAL INC

Regulatory identity

EU manufacturer SRN: US-MF-000005202
EU authorised representative: Medical Technology Promedt Consulting GmbH
UK responsible person: MT Promedt Consulting Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00840270603286	OPPO GENU S	Class I
EU	00840270602876	OPPO GENU S	Class I
EU	00840270602883	OPPO GENU S	Class I
EU	00840270602890	OPPO GENU S	Class I
UK	47218	Hernia Truss Double-Sided	Class I
UK	36206	Adjustable Ankle Support	Class I
UK	12095	Arm Sling	Class I
BR	80041210096	Tensores OPPO	Class I
BR	80041210100	ÓRTESES PARA COLUNA	Class I

OPPO MEDICAL INC.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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