HomeChinaCardiolink Science(Shenzhen)Medical Technology Development Co.,Ltd.

Cardiolink Science(Shenzhen)Medical Technology Development Co.,Ltd.

China · 深圳 · keruichi.cent.uoeee.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000037464Unified social credit code 91440300359685384R

This company holds 19 NMPA certificates in China and has registrations in European Union, Brazil — 2 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
19China registrations
Class III 19
as of 2026-09-04
EUEuropean UnionEUDAMED
≥300UDI-DI device records
Class IIa 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
8registered devices
Class II 8
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 Union827 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
China19 certificates (Class III 19 / II 0 / I 0), as of 2026-09-04
Brazil8 confirmed, 0 excluded
Manufacturer names merged into this page: CARDIOLINK SCIENCE (SHENZHEN) MEDICAL TECHNOLOGY DEVELOPMENT CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000037464
EU authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Unified social credit code
91440300359685384R
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
175
Annual revenue
RMB 50–100M
Website
keruichi.cent.uoeee.com
Product categories
手术器械植入器械

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
2015-12-30
Registered capital
CNY 20,849,120
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (Sino-foreign joint venture)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-05-07
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. 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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263031409一次性使用介入微导管Class III
CN国械注准20253131010聚乙烯醇栓塞微球Class III
CN国械注准20253130676聚乙烯醇栓塞微球Class III
CN国械注准20243130946栓塞微球Class III
EU06971741701119Class IIa
EU06971741701102Class IIa
EU06971741701096Class IIa
EU06971741701089Class IIa
BR82195309001Microcateter IntervencionalClass II
BR82195309003MicrocateterClass II
BR82195309004Micro Fio-GuiaClass II

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