Identity
- Trade Name
- Alvision EUDAMED
- Device Name
- Alvision Interventional Cardiology Diagnostic Catheter EUDAMED
- Model / Reference
- 501110188415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699195526260 EUDAMED
- Basic UDI-DI
- 086991955Alvision5D EUDAMED
- Direct Marketing DI
- 08699195526260 EUDAMED
- EMDN Code
- C0104010101 CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS EUDAMED
Classification
- Device Class
- Class III 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
Alvision by Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. — Class III — 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 | 086991955Alvision5D | Class III | Active |
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Manufacturer
- Manufacturer
- Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.
- EUDAMED SRN
- TR-MF-000029915
Sources (1)
- EUDAMED ec03f1aa-d5ae-43a3-9fc8-c1e546791336 61 fields · synced Oct 5, 2026