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heyer medical AG

Germany · Schwerin · www.heyermedical.de

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000014712

This company has registrations in European Union, United Kingdom, Brazil, South Korea, Russia — 5 overseas markets. EU UDI-DI records ≥18, 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

≥18UDI-DI device records

Class I 3Class IIa 13IVD C 2

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

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 IIa 2Custom-made - Class IIa 1

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

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

6active registrations

Class 2a 6

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 Union762 raw hits, 282 excluded, 18 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 3 excluded

United Kingdom3 confirmed, 1 excluded

Brazil2 confirmed, 1 excluded

Manufacturer names merged into this page: HEYER MEDICAL CO. ,LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000014712
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: HEADINGTON MEDICAL TECHNOLOGY LTD

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06972733992065	Surgical Lights	Class I
EU	06972733992041	Surgical Lights	Class I
EU	06972733992058	Surgical Lights	Class I
EU	04251743800303	LUVAR II	Class IIa
UK	57814	CPAP NASAL MASK	Custom-made - Class IIa
UK	60712	CPAP and BPAP	Class IIa
UK	60711	CPAP and BPAP	Class IIa
BR	82036520027	FAMÍLIA OL9600	Class I
BR	82036520029	FAMÍLIA OL9500	Class I

heyer medical AG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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