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
- MR14040050B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224905211 EUDAMED
- Basic UDI-DI
- B-18904224905211 EUDAMED89042249RPTABDC014A4 EUDAMED
- Direct Marketing DI
- 18904224905211 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
MozecTM PTA 0.014"Rx by Meril Life Sciences Pvt. Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-18904224905211 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-18904224905211 | 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 9742fb58-b2b6-459d-8185-57302b7cd06e 61 fields · synced Jul 30, 2026
- EUDAMED 9960691b-12f2-464f-9ccd-9d4abf26c0c1 61 fields · synced Jul 30, 2026