Identity
- Trade Name
- Simpass EUDAMED
- Device Name
- Simpass Endo14 RX PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- Simpass Endo14 EUDAMEDSPE20030-90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699343612784 EUDAMED
- Basic UDI-DI
- 86993436PTA14RX8H EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS 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
Simpass by Simeks Tibbi Urunler San. ve Tic LTD STI — 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 | 86993436PTA14RX8H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Simeks Tibbi Urunler San. ve Tic LTD STI
- EUDAMED SRN
- TR-MF-000015871
Sources (1)
- EUDAMED 438d4479-4cab-44af-8d83-93f35cf55705 61 fields · synced Oct 5, 2026