Identity
- Trade Name
- Mozec™ NC EUDAMEDMozecTM NC Rx PTCA Balloon Dilatation Catheter FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- Mozec™ NC - Rx PTCA Balloon Dilatation Catheter EUDAMEDMozecTM NC Rx PTCA Balloon Dilatation Catheter, 4.00 mm x 38 mm, Rapid Exchange FDA UDI
- Model / Reference
- MNC40038 EUDAMEDFDA UDI
- Description
- MozecTM NC Rx PTCA Balloon Dilatation Catheter, 4.00 mm x 38 mm, Rapid Exchange FDA UDI
Identifiers
- Catalog Number
- MNC40038 FDA UDI
- Primary DI / UDI-DI
- 18906029359480 EUDAMEDFDA UDI
- Basic UDI-DI
- B-18906029359480 EUDAMED
- FDA Product Code
- LOX FDA UDI
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5100 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 38 Millimeter FDA UDIOuter Diameter — 4.00 Millimeter FDA UDI
Mozec™ NC by Meril Life Sciences Pvt. Ltd. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18906029359480 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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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 8a747ade-87e0-44d8-b4e7-8e7786d64fb9 61 fields · synced Jun 19, 2026
- FDA UDI ea089389-e558-4c79-b248-0d4d3752e8c4 37 fields · synced May 30, 2026