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ShenZhen Bi-rich Medical Devices Co., Lt

China · Shenzhen Guangdong Province · www.bi-rich.cn

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000023061

This company has registrations in European Union, United States, United Kingdom, Israel — 4 overseas markets. EU UDI-DI records ≥1, 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

≥1UDI-DI device records

Class IIa 1

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

USUnited StatesFDA openFDA

9listed device types

Class I 3Class II 6Class III 0

plus 11 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

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

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 Union4,661 raw hits, 299 excluded, 1 confirmed. Large result set — only the first 300 verified

United States11 registration records, 1 510(k), 0 PMA, 1 excluded

United Kingdom1 confirmed, 28 excluded

Brazil0 confirmed, 1 excluded

Manufacturer names merged into this page: SHENZHEN BI-RICH MEDICAL DEVICES CO., LTD · Bi-Rich Medical Devices (Cambodia) Co. Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000023061
EU authorised representative: SUNGO Europe B.V.
UK responsible person: A&D Instruments Ltd

FDA 510(k) clearances by year

12026 · K252802

FDA listed device types

showing 8 of 9

Meter, Peak Flow, Spirometry 1Vacuum Powered Body Fluid Collection Kit 1Nebulizer (Direct Patient Interface) 1Compressor, Air, Portable 1Tube, Aspirating, Flexible, Connecting 1Pump, Portable, Aspiration (Manual Or Powered) 1Unit, Filter, Membrane 1Mask, Oxygen, Non-Rebreathing 1

Market	Identifier	Name	Class / date
EU	06975070916053	Microlife	Class IIa
UK	66295	A&D Medical	Class IIa
US	K252802	Peak Flow Meter (PF-10(BR-PEF231))	2026-05-29

ShenZhen Bi-rich Medical Devices Co., Lt

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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