HomeChinaBQ PLUS MEDICAL CO.,LTD

BQ PLUS MEDICAL CO.,LTD

China · Shanghai · www.bq-md.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000010259

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Hong Kong, Israel — 9 overseas markets. 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
283UDI-DI device records
Class I 228Class IIa 55
USUnited StatesFDA openFDA
13listed device types
Class I 2Class II 11Class III 0
plus 25 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
14registered device records
Class I 2Class IIa 12
BRBrazilANVISA
20registered devices
Class I 6Class II 14
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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 2Manufacturing 1
AUAustraliaTGA ARTG
13active ARTG entries
IIa 11Class Is (sterile) 2
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
3registrations
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 Union298 raw hits, 15 excluded, 283 confirmed
United States25 registration records, 3 510(k), 0 PMA
United Kingdom14 confirmed, 1 excluded
Brazil20 confirmed, 0 excluded
Manufacturer names merged into this page: BQ PLUS MEDICAL CO.,LTD · BQ PLUS MEDICAL CO., LTD. · BQ PLUS MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000010259
EU authorised representative
Prolinx GmbH
UK responsible person
lotus global co ltd

Company information

Country
China
City
Shanghai
Website
www.bq-md.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentCardiology & vascular medicineOncology & Advanced TherapiesMedical oncology devicesIntegrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12021 · K210381
12023 · K223645
12024 · K242126

FDA listed device types

showing 8 of 13
Mask, Gas, Anesthetic 1Dispenser, Liquid Medication 1Endoscope Channel Accessory 1Endoscopic Injection Needle, Gastroenterology-Urology 1Arthroscope 1Syringe, Piston 1Colonoscope And Accessories, Flexible/Rigid 1Stent, Ureteral 1

Registration details (sample)

MarketIdentifierNameClass / date
EU06972620114082Class IIa
EU06972620114105Class IIa
EU06972620114099Class I
EU06972620113719Class I
UK46232Anesthesia Face MasksClass IIa
UK58092Heparin CapsClass IIa
UK38569Burettes Transfusion SetsClass IIa
USK242126I.V. Administration Set2024-08-22
USK223645I.V. Administration Set, I.V. Extension Set2023-05-18
USK210381I.V. Administration Set2021-08-14
BR81333810010EQUIPOS DE USO ÚNICO DE INFUSÃO GRAVITACIONALClass I
BR81245769030F-02 Equipos para bomba de infusão macrogotas fotossensívelClass II
BR81245769031F-01 Equipos para bomba de infusão macrogotasClass II

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