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Primelife
EUDAMEDClass IIa (EU MDR)
Ref 158144Model Straight tip, J tip, Angle tip
Identity
- Trade Name
- PRIMELIFE EUDAMED
- Device Name
- Guidewire EUDAMED
- Model / Reference
- Straight tip, J tip, Angle tip EUDAMED158144 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841238620 EUDAMED
- Basic UDI-DI
- 697116281GW15GY EUDAMED
- EMDN Code
- C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC 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 | 697116281GW15GY | 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 0aa2473c-9ae4-4408-8e5f-cdab69ea1b92 61 fields · synced Jun 18, 2026