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MIR Medical International Research

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

4listed device types

Class I 1Class II 3Class III 0

plus 8 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 2Class IIa 3

BRBrazilANVISA

5registered devices

Class I 2Class II 3

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

14 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

7device registrations

CLASS B 7

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

4registrations

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 Union3,144 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States8 registration records, 12 510(k), 0 PMA

United Kingdom5 confirmed, 23 excluded

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. · MIR MEDICAL INTERNATIONAL RESEARCH S.P.A · MIR MEDICAL INTERNATIONAL RESEARCH S.P.A.

Regulatory identity

UK responsible person: QCS International LTD.
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
UK	62641	Cardionica	Class IIa
UK	42489	Cardionica Patch	Class I
UK	46906	FlowMir	Class I
US	K230501	Spirobank Oxi	2023-12-15
US	K181666	Smart One	2018-08-01
US	K130784	SPIROTEL	2013-10-30
BR	80441730004	ESPIROMETRO MIR	Class II
BR	80441730005	ESPIROMETRO MIR	Class II
BR	80441730002	ESPIRÔMETRO MIR	Class II

MIR Medical International Research

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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