BIOPTRON AG

Switzerland · Wollerau · www.bioptron.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN CH-MF-000041313

This company has registrations in European Union, United States, Canada, Singapore, Hong Kong, Israel, Russia — 7 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

3UDI-DI device records

Class IIa 3

USUnited StatesFDA openFDA

2listed device types

Class I 1Class II 1Class III 0

plus 3 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

2active device licences

Class II 2

5 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 raw hits, 0 excluded, 3 confirmed

United States3 registration records, 1 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: BIOPTRON AG

Regulatory identity

EU manufacturer SRN: CH-MF-000041313
EU authorised representative: MDR Regulator Sp. z o. o.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	76126750028880	BIOPTRON MedAll	Class IIa
EU	76126750024752	BIOPTRON B2	Class IIa
EU	76126750012636	—	Class IIa
US	K032216	BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM	2004-02-04
CA	105902	BIOPTRON PRO1	Class II
CA	105904	BIOPTRON MEDALL	Class II

BIOPTRON AG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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