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Wearable Technologies AG

Germany · Herrsching am Ammersee · www.wearable-technologies.com

✓ Record-verifiedregistrations found in 2 marketsEU SRN US-MF-000044036

This company has registrations in European Union, United States — 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

4UDI-DI device records

Class I 4

USUnited StatesFDA openFDA

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 0 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

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.

European Union6 raw hits, 2 excluded, 4 confirmed

United States1 registration records, 0 510(k), 0 PMA

Manufacturer names merged into this page: APDM Wearable Technologies, Inc.

Regulatory identity

EU manufacturer SRN: US-MF-000044036
EU authorised representative: eResearchTechnology GmbH
UK responsible person: Exco InTouch Limited (Now Part of Clario)

Market	Identifier	Name	Class / date
EU	00850067173038	Opal DataHub V2C	Class I
EU	00850067173014	Docking Station V2C	Class I
EU	00850067173021	Access Point V2C	Class I
EU	00850067173007	Opal V2C	Class I

Wearable Technologies AG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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