HomeChinaQingdao Bright Moon Biomedical Materials Co Ltd

Qingdao Bright Moon Biomedical Materials Co Ltd

China · 青岛 · www.bmbm.cn
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000021492Unified social credit code 91370211599023611B

This company holds 6 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
6China registrations
Class I 4Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
32UDI-DI device records
Class IIa 32
USUnited StatesFDA openFDA
6listed device types
Class I 5Class II 0Class III 0unclassified 1
plus 7 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
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 Union35 raw hits, 3 excluded, 32 confirmed
United States7 registration records, 2 510(k), 0 PMA, 5 excluded
China6 certificates (Class III 2 / II 0 / I 4), as of 2026-09-04
United Kingdom0 confirmed, 3 excluded
Manufacturer names merged into this page: QINGDAO BRIGHT MOON BIOMEDICAL MATERIALS CO LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000021492
EU authorised representative
Prolinx GmbH
Unified social credit code
91370211599023611B
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
80
Annual revenue
RMB 10–30M
Website
www.bmbm.cn
Product categories
医用耗材医用影像养生保健及食品医用电子手术室及急救

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.

Business registration

Registration status
Active
Incorporated
2012-08-08
Registered capital
CNY 45,454,545
Paid-in capital
CNY 39,318,200
Legal form
Limited liability company (foreign-invested, not wholly owned)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-10-23
Recognitions
Micro and small enterpriseNational High-Tech Enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12023 · K220673
12025 · K252167

FDA listed device types

Dressing, Wound, Hydrophilic 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1Bandage, Elastic 1Elastomer, Silicone, For Scar Management 1Dressing, Wound, Occlusive 1Dressing, Wound, Drug 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20223141643羧甲基纤维素钠纤维敷料Class III
CN国械注准20173141594藻酸盐敷料Class III
CN鲁青械备20240391敷料镊Class I
CN鲁青械备20240099创口贴Class I
EU06934889081031Sterile Alginate Wound DressingClass IIa
EU06934889081611Sterile Alginate Wound DressingClass IIa
EU06934889081604Sterile Alginate Wound DressingClass IIa
EU06934889081598Sterile Alginate Wound DressingClass IIa
USK252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)2025-12-19
USK220673Sterile Silver Alginate Wound Dressing2023-03-16

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