HomeChinaXiamen Tianzuo Medical Co.,Ltd.

Xiamen Tianzuo Medical Co.,Ltd.

China · 厦门 · www.tzmed.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000018733Unified social credit code 9135021258129101XF

This company holds 35 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
35China registrations
Class I 22Class II 13
as of 2026-09-04
EUEuropean UnionEUDAMED
101UDI-DI device records
Class I 101
USUnited StatesFDA openFDA
3listed device types
Class I 2Class II 1Class III 0
plus 3 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 2Class IIa 1
BRBrazilANVISA
5registered devices
Class I 2Class II 3
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
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union101 raw hits, 0 excluded, 101 confirmed
United States3 registration records, 0 510(k), 0 PMA
China35 certificates (Class III 0 / II 13 / I 22), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: Xiamen Tianzuo Medical Co., Ltd. · XIAMEN TIANZUO MEDICAL CO.,LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000018733
EU authorised representative
MedPath GmbH
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
9135021258129101XF
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
114
Annual revenue
RMB 50–100M
Website
www.tzmed.com
Product categories
呼吸、麻醉和急救器械手术室及急救医用耗材康复 & 养老注输、护理和防护器械

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
2011-11-29
Registered capital
CNY 2,400,000
Paid-in capital
CNY 2,400,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2026-06-03
Recognitions
Micro and small enterpriseNational High-Tech Enterprise
Listing
Listed on a regional equity market

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 listed device types

Mask, Gas, Anesthetic 1Mask, Oxygen, Non-Rebreathing 1Valve, Non-Rebreathing 1

Registration details (sample)

MarketIdentifierNameClass / date
CN闽械注准20262090052一次性使用无菌麻醉面罩Class II
CN闽械注准20262080105一次性使用雾化面罩Class II
CN闽械注准20262080104一次性使用输氧面罩Class II
CN闽械注准20262080098一次性使用雾化吸入管Class II
EU06970385729497Spacer For AerosolClass I
EU06970385729480Spacer For AerosolClass I
EU06970385729473Spacer For AerosolClass I
EU06970385729466Spacer For AerosolClass I
UK61326Resuscitation MaskClass I
UK41039Extrication CollarClass I
UK36086Silicone/SEBS/PVCManual Resuscitator(Masks, Positive End Expiratory Pressure Valve, Oxygen Tube, Reservoir)Class IIa
BR81504790553NEBULIZADOR MÉDICOClass II
BR82405099009REANIMADOR MANUAL DESCARTÁVEL MEDICAL FLEXClass II
BR10224629056Reanimador Manual Modelo 021Class II

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