Identity
- Trade Name
- Invader PTCA EUDAMED
- Device Name
- Invader PTCA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 512110021554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699195505302 EUDAMED
- Basic UDI-DI
- 086991955InvaderPTCAVA EUDAMED
- Direct Marketing DI
- 08699195505302 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION 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
Invader PTCA 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 | 086991955InvaderPTCAVA | 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 97952786-6f2a-4206-8a41-8fa2fd18aaec 61 fields · synced Oct 6, 2026