Identity
- Trade Name
- PRIMELIFE EUDAMED
- Device Name
- Balloon Inflation Device EUDAMED
- Model / Reference
- BID1, BID2, BID3 EUDAMED101007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841238866 EUDAMED
- Basic UDI-DI
- 697116281BID10AJ EUDAMED
- EMDN Code
- C0104010280 INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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 I — 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 | 697116281BID10AJ | Class I | 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 9fcdf151-e175-4bee-bcfc-c6ee4c7114ef 61 fields · synced Oct 8, 2026