HomeChinaQingdao Hainuo biological engineering co.,ltd

Qingdao Hainuo biological engineering co.,ltd

China · 青岛 · www.hainuocn.com
✓ Record-verifiedregistrations found in 6 marketsUnified social credit code 913702857180717488

This company holds 22 NMPA certificates in China and has registrations in United States, Brazil, Saudi Arabia, Australia, Russia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
22China registrations
Class I 21Class II 1
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
5registered devices
Class I 5
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2b 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.

United States0 registration records, 1 510(k), 0 PMA
China22 certificates (Class III 0 / II 1 / I 21), as of 2026-09-04
Brazil5 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD

Regulatory identity

Unified social credit code
913702857180717488
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Employees
1000–5000
Annual revenue
over RMB 500M
Company type
有限责任公司
Website
www.hainuocn.com
Product categories
医用耗材

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 · K210218

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20252140103可调式鼻腔清洗器Class II
CN鲁青械备20230718鼻部冲洗器Class I
CN鲁青械备20230451号棉片Class I
CN鲁青械备20220613号隔离透声膜Class I
USK210218SURGICAL MASK, Model Name:C0152021-05-07
BR80250540028LIQUID BANDAGEClass I
BR80250540016Fever Relief PatchClass I
BR80250540018I.V. Adhesive dressingClass I
SAME0000004298SFDAA00002Santavik

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