← Back to catalogue
Introducer Sheath
EUDAMEDClass IIa (EU MDR)
Ref 052009Model Femoral 4F, Femoral 5F, Femoral 6F, Femoral 7F, Femoral 8F, Femoral 9F, Femoral 10F, Femoral 11F, Femoral 12F, Radial 3F, Radial 4F, Radial 5F, Radial 6F, Radial 7F, Radial 8FRef 051007Ref 052001Ref 052004Ref 051005Ref 051009
Identity
- Device Name
- Introducer Sheath EUDAMED
- Model / Reference
- Femoral 4F, Femoral 5F, Femoral 6F, Femoral 7F, Femoral 8F, Femoral 9F, Femoral 10F, Femoral 11F, Femoral 12F, Radial 3F, Radial 4F, Radial 5F, Radial 6F, Radial 7F, Radial 8F EUDAMED052009 EUDAMED051007 EUDAMED052001 EUDAMED052004 EUDAMED051005 EUDAMED051009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162812005 EUDAMED06971162813910 EUDAMED06971162811923 EUDAMED06971162811954 EUDAMED06971162813903 EUDAMED06971162813927 EUDAMED
- Basic UDI-DI
- 69368412IS05TV EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Interventional radiology percutaneous-access kit, single-use
Introducer Sheath by Tianck Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
- Access Needle — Mermaid Medical A/S · Class I
- EXTesia — Curatia Medical Limited · Class IIa
- SWL-Pathfinder — SWL Medizin GmbH · Class III
- Mini Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Introducer Set — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69368412IS05TV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED d900a28b-c67b-443e-bef7-e60ffe6bc5f0 61 fields · synced Jul 22, 2026
- EUDAMED 247b3686-cd8f-41d8-8575-3edb984ecc67 61 fields · synced May 18, 2026
- EUDAMED b697a9ee-64f3-4cb1-9945-48284b77657b 61 fields · synced May 18, 2026
- EUDAMED bb3ad05c-6868-4071-8e4c-1b0cc2ca064e 61 fields · synced May 18, 2026
- EUDAMED ce506acb-8050-4bb8-b401-ae6bcea4ed30 61 fields · synced May 19, 2026
- EUDAMED 36641e6c-03f5-45da-8ac8-24a6cb989643 61 fields · synced May 19, 2026