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Primelife
EUDAMEDClass IIa (EU MDR)
Ref 052166Model 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
- Trade Name
- PRIMELIFE EUDAMED
- 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 EUDAMED052166 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841238781 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
Primelife by Tianck Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 7a8f605b-e3d4-452c-8bdf-8355ef679ff2 61 fields · synced Oct 7, 2026