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Innovation Biotech (Beijing) Co., Ltd

✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000032023

This company has registrations in European Union, United States, United Kingdom, Brazil — 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

ivd-devices-self-testing 1

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

USUnited StatesFDA openFDA

33listed device types

Class I 7Class II 24Class III 0unclassified 2

plus 14 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

4registered device records

IVD general 2IVD Devices for Self-Testing 2

BRBrazilANVISA

0registered devices

1 including historic records

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

pendingnot queried

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 Union3,865 raw hits, 299 excluded, 1 confirmed. Large result set — only the first 300 verified

United States14 registration records, 10 510(k), 0 PMA, 99 excluded

United Kingdom4 confirmed, 64 excluded

Brazil0 confirmed, 25 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 18 excluded

Manufacturer names merged into this page: CO-INNOVATION BIOTECH CO.,LTD. · Beijing Technology Co - Innovation Center · BEIJING BOHUI INNOVATION BIOTECHNOLOGY GROUP CO. LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000032023
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: CMC Medical Devices LTD

FDA 510(k) clearances by year

12013

42014 · K142800

12016 · K153050

12022 · K213808

32024 · K241100

FDA listed device types

showing 8 of 33

Toothbrush, Powered 1Test System, Nicotine, Cotinine, Metabolites 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Unit, Oral Irrigation 1Toothbrush, Manual 1Radioimmunoassay, Luteinizing Hormone 1Heat Source For Bleaching Teeth 1Kit, Test, Pregnancy, Hcg, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06970429842021	MomMed Pregnancy Test	ivd-devices-self-testing
UK	54255	One Step Luteinizing Hormones (LH) Test	IVD Devices for Self-Testing
UK	64756	One Step 2019-Novel Coronavirus (2019-nCoV) IgG/IgM Test Cassette	IVD general
UK	65352	One Step 2019-nCoV Neutralizing Antibody Test	IVD general
US	K241100	Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard	2024-05-22
US	K231904	Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard	2024-03-08
US	K232732	Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50	2024-01-17

Innovation Biotech (Beijing) 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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