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Introducer Sheath
EUDAMEDClass IIa (EU MDR)
Ref 052002Model 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
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 EUDAMED052002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162811930 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.
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- 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 |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c24144a8-4ac4-41ab-ab94-dcf0720cb490 61 fields · synced Jun 18, 2026