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Shanghai REACH Medical Instrument Co.,Ltd.

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000010269

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Australia, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥300, 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

pendingnot queried

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 95Class IIa 18Class III 187

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

USUnited StatesFDA openFDA

31listed device types

Class I 28Class II 3Class III 0

plus 32 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 1Class IIa 1Class IIb 5

BRBrazilANVISA

2registered devices

Class I 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 2IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 Union3,029 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States32 registration records, 3 510(k), 0 PMA, 6 excluded

United Kingdom7 confirmed, 3 excluded

Brazil2 confirmed, 4 excluded

Saudi Arabia0 confirmed, 2 excluded

Manufacturer names merged into this page: SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD · REACH MEDICAL, INC. · SHANGHAI REACH MEDICAL INSTRUMENT CO.,LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000010269
EU authorised representative: CMC Medical Devices & Drugs SL
UK responsible person: SUNGO Certification Company Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06926555496898	Mechanical Arm	Class I
EU	06926555496881	Hook 90(W)	Class I
EU	06926555496874	Hook 90(N)	Class I
EU	06926555496867	Hook 70(W)	Class I
UK	61324	Sterile Posterior Spinal Fixation System	Class IIb
UK	61324	Posterior Spinal Fixation System	Class IIb
UK	64192	Orthopedic Instrument	Class I
US	K232069	Expandable Lumbar Fusion Cage (Type I,Type II)	2023-11-29
US	K221745	Sterile Posterior Spinal Fixation System	2022-08-31
US	K201737	Posterior Spinal Fixation System	2021-06-21
BR	81588840013	Instrumentais SCORPN	Class I
BR	81588840008	Hanfuse Instrumentais	Class I

Shanghai REACH Medical Instrument Co.,Ltd.

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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