Identity
- Trade Name
- Simpass EUDAMED
- Device Name
- Simpass Endo35 OTW PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- Simpass Endo35 OTW EUDAMEDSE12040-130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699343602587 EUDAMED
- Basic UDI-DI
- 86993436PTA35OTWHL 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
Category: Peripheral angioplasty balloon catheter, basic
Simpass by Simeks Tibbi Urunler San. ve Tic LTD STI — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
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 | 86993436PTA35OTWHL | 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 39a5a897-d7bb-49cc-9a6c-552fbd315c7a 61 fields · synced Jun 17, 2026