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Mozec™ PTA 0.035" OTW
EUDAMEDClass IIa (EU MDR)
Ref MO35070080AModel Usable length 800 mm
Identity
- Trade Name
- Mozec™ PTA 0.035" OTW EUDAMED
- Device Name
- Mozec™ PTA 0.035" OTW Balloon Dilatation Catheter EUDAMED
- Model / Reference
- Usable length 800 mm EUDAMEDMO35070080A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224901947 EUDAMED
- Basic UDI-DI
- B-18904224901947 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
Mozec™ PTA 0.035" OTW by Meril Life Sciences Pvt. Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
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- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
- Simpass — Simeks Tibbi Urunler San. ve Tic LTD STI · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18904224901947 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000008308
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED e005de77-f381-4e58-8063-47c0feb7fe0d 61 fields · synced Jun 19, 2026