Identity
- Trade Name
- MozecTM PTA 0.014"Rx EUDAMEDMozec™ PTA 0.014"Rx EUDAMED
- Device Name
- MozecTM PTA 0.014"Rx Balloon Dilatation Catheter EUDAMEDMozec™ PTA 0.014"Rx Balloon Dilatation Catheter EUDAMED
- Model / Reference
- MR14035060B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224905150 EUDAMED
- Basic UDI-DI
- B-18904224905150 EUDAMED89042249RPTABDC014A4 EUDAMED
- Direct Marketing DI
- 18904224905150 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPoland 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
MozecTM PTA 0.014"Rx by Meril Life Sciences Pvt. Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- Armada — Abbott Vascular · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-18904224905150 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-18904224905150 | 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 (2)
- EUDAMED 5f00256c-6ba7-4999-a5c4-8fc8414d417d 61 fields · synced Jul 30, 2026
- EUDAMED 4177b9b3-e7b4-4272-94d5-b423bff18535 61 fields · synced Jul 20, 2026