HomeChinaQINHUANGDAO TAIZHI MEDICAL TECHNOLOGY CO. LTD

QINHUANGDAO TAIZHI MEDICAL TECHNOLOGY CO. LTD

China · 秦皇岛 · www.qhdtzyl.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000010446Unified social credit code 91130302MA0EKB543N

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Australia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
6China registrations
Class II 6
as of 2026-09-04
EUEuropean UnionEUDAMED
2UDI-DI device records
Class I 2
USUnited StatesFDA openFDA
5listed device types
Class I 2Class II 2Class III 0unclassified 1
plus 7 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class I 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
1active ARTG entries
Class I 1
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 Union2 raw hits, 0 excluded, 2 confirmed
United States7 registration records, 3 510(k), 0 PMA
China6 certificates (Class III 0 / II 6 / I 0), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Manufacturer names merged into this page: QINHUANGDAO TAIZHI MEDICAL TECHNOLOGY CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000010446
EU authorised representative
RIOMAVIX SOCIEDAD LIMITADA
UK responsible person
SHARE INFO LTD
Unified social credit code
91130302MA0EKB543N
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
102
Annual revenue
RMB 30–50M
Website
www.qhdtzyl.com
Product categories
注输、护理和防护器械药品

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
2020-02-27
Registered capital
CNY 110,000,000
Paid-in capital
CNY 94,660,000
Legal form
Limited liability company
Industry classification
Technology promotion and application services
Last approval date
2026-03-20
Recognitions
National High-Tech EnterpriseTechnology-based SMEInnovative SME

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

22021 · K212205
12023 · K223686

FDA listed device types

Mask, Surgical 1Respirator, Surgical 1Shield, Protective, Personnel 1Mask, Scavenging 1Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua 1

Registration details (sample)

MarketIdentifierNameClass / date
CN冀械注准20212140045一次性使用医用口罩Class II
CN冀械注准20212140044医用防护口罩Class II
CN冀械注准20212140043一次性医用外科口罩Class II
CN冀械注准20212140042医用防护口罩Class II
EU06973274101060Class I
EU06973274100209Class I
UK66199Disposable Surgical MaskClass I
USK223686Medical Protective Masks2023-02-07
USK212205Medical Protective Masks2021-10-14
USK211451Disposable Surgical Mask (non sterile)2021-08-25

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