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Introducer Set
EUDAMEDClass IIa (EU MDR)
Ref 052006Model Femoral 7F×11cmModel 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 051021Model Radial 6Fx11cm
Identity
- Device Name
- Introducer Set EUDAMEDIntroducer Sheath EUDAMED
- Model / Reference
- Femoral 7F×11cm EUDAMED052006 EUDAMEDFemoral 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 EUDAMEDRadial 6Fx11cm EUDAMED051021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162811978 EUDAMED06971162817949 EUDAMED
- Basic UDI-DI
- B-06971162811978 EUDAMED69368412IS05TV EUDAMEDB-06971162817949 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 Set by Tianck Medical Co., Ltd. — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971162811978 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971162811978 | 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 (3)
- EUDAMED 3d9674dc-19c7-40d2-a7c6-aaf6ec9cff60 61 fields · synced Jul 21, 2026
- EUDAMED f21a78cc-04fd-4634-bc46-9af2fe36eb8a 61 fields · synced May 18, 2026
- EUDAMED 25fd9755-6f14-4309-a9a2-d6ee9d1a05cd 61 fields · synced Jul 21, 2026