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Tandem Health Global GmbH

Germany · Mannheim · www.tandemhealth.ai

✓ Record-verifiedregistrations found in 2 marketsEU SRN SE-MF-000049463

This company has registrations in European Union, United Kingdom — 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

3UDI-DI device records

Class IIa 3

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 1Class IIa 3

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 Union29 raw hits, 26 excluded, 3 confirmed

United States0 registration records, 0 510(k), 0 PMA, 7 excluded

United Kingdom4 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN: SE-MF-000049463
UK responsible person: TANDEM HEALTH GLOBAL LIMITED

Registration details (sample)

Market	Identifier	Name	Class / date
EU	07350179820026	—	Class IIa
EU	07350179820033	—	Class IIa
EU	07350179820019	—	Class IIa
UK	61087	Tandem AI Medical Coder	Class IIa
UK	61087	Tandem AI Medical Guide	Class IIa
UK	36216	Tandem AI Medical Scribe	Class IIa

Tandem Health Global GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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