HomeChinaTianck Medical Co., Ltd.

Tianck Medical Co., Ltd.

China · 深圳 · www.tianck.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000007451Unified social credit code 91440300MA5DL18M6R

This company holds 27 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Israel, Russia — 7 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
27China registrations
Class II 18Class III 9
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class I 21Class IIa 278Class IIb 1
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
10listed device types
Class I 5Class II 5Class III 0
plus 10 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIa 1
BRBrazilANVISA
67registered devices
Class I 10Class II 57
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
2GMP quality-system certificates
Business type not stated 1Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 Union474 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States10 registration records, 0 510(k), 0 PMA
China27 certificates (Class III 9 / II 18 / I 0), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Brazil67 confirmed, 0 excluded
Manufacturer names merged into this page: TIANCK MEDICAL CO.,LTD · TIANCK MEDICAL CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000007451
EU authorised representative
Lotus NL B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91440300MA5DL18M6R
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
103
Website
www.tianck.com
Product categories
输血、透析和体外循环器械手术室及急救医用电子医用耗材输血及体外循环妇产及生殖

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
2016-09-14
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company
Industry classification
Pharmaceutical manufacturing
Last approval date
2024-05-22
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseInnovative 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 listed device types

showing 8 of 10
Tourniquet, Pneumatic 1Needle, Catheter 1Accessories, Arthroscopic 1Guide, Needle, Surgical 1Cannula, Injection 1Catheter And Tip, Suction 1Trocar 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253030575一次性使用无菌中心静脉导管Class III
CN国械注准20243101468一次性使用无菌血液透析导管Class III
CN国械注准20243070386一次性使用有创血压传感器Class III
CN国械注准20243032214一次性使用导引导管Class III
EU06936841238682PRIMELIFEClass IIa
EU06936841238699PRIMELIFEClass IIa
EU06936841238705PRIMELIFEClass IIa
EU06936841238712PRIMELIFEClass IIa
UK58115GuidewiresClass IIa
BR80253920012Fio guia hidrofílico - Tianck Medical.Class II
BR80253929010CATETER PARA DRENAGEM EXTERNA COM ACESSÓRIOS TIANCKClass II
BR80253929011Cateter ureteral Duplo JClass II

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