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EM-MED Sp. z o.o. Sp. K.

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United Kingdom, Brazil, Taiwan, Israel — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

Class I 2Class IIb 1

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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 II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 Union192,018 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 14 excluded

United Kingdom3 confirmed, 599 excluded

Brazil2 confirmed, 34 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: EM-MED SP. Z O. O. SP. K. · EM-MED SP. ZO.O. SP. K.

Regulatory identity

UK responsible person: Eurolink (Europe) Limited

Market	Identifier	Name	Class / date
UK	36172	TrueCool	Class IIb
UK	33512	EmTherm	Class I
UK	40516	EmTherm	Class I
BR	80443690007	EMTHERM	Class I
BR	80271299016	TRUECOOL	Class II

EM-MED Sp. z o.o. Sp. K.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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