Identity
- Trade Name
- Simpass EUDAMED
- Device Name
- Simpass NC HP RX PTCA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- Simpass NC HP EUDAMEDSNC22525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699343615815 EUDAMED
- Basic UDI-DI
- 86993436PTCANC7S 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
Category: Coronary angioplasty balloon catheter, cutting/scoring
Simpass by Simeks Tibbi Urunler San. ve Tic LTD STI — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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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 | 86993436PTCANC7S | 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 c4d7782d-c939-4160-b3b1-9649b2e87002 61 fields · synced Jun 18, 2026