Identity
- Trade Name
- Simpass EUDAMED
- Device Name
- Simpass Plus RX PTCA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- Simpass Plus EUDAMEDPS30020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699343604352 EUDAMED
- Basic UDI-DI
- 86993436PTCASC89 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
Simpass by Simeks Tibbi Urunler San. ve Tic LTD STI — 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 | 86993436PTCASC89 | Class III | Active |
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Manufacturer
- Manufacturer
- Simeks Tibbi Urunler San. ve Tic LTD STI
- EUDAMED SRN
- TR-MF-000015871
Sources (1)
- EUDAMED 98b386ec-9707-4b1e-b4a4-823d4cdb6487 61 fields · synced Oct 5, 2026