Identity
- Trade Name
- Mozec™ PTA 0.014" OTW EUDAMED
- Device Name
- Mozec™ PTA Balloon Dilatation Catheter OTW 0.014" EUDAMEDMozec™ PTA Balloon Dilatation Catheter OTW 0.014 EUDAMED
- Model / Reference
- MO14040080B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224917160 EUDAMED
- Basic UDI-DI
- B-18904224917160 EUDAMED89042249OPTABDC0147D EUDAMED
- Direct Marketing DI
- 18904224917160 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMEDC010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Mozec™ PTA 0.014" OTW by Meril Life Sciences Pvt. Ltd. — Class IIa — MDR, 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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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-18904224917160 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-18904224917160 | 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 504758fc-da94-4c5b-bdb0-5de5d9df87d4 61 fields · synced Jun 19, 2026
- EUDAMED ea0ebeb0-3959-4919-98c4-d470f8ee73ff 61 fields · synced Jun 19, 2026