Identity
- Trade Name
- Nexgen™ EUDAMED
- Device Name
- NexGen™ Cobalt Chromium Coronary Stent System EUDAMED
- Model / Reference
- Model 1 EUDAMEDNXG25019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18906029350135 EUDAMED
- Basic UDI-DI
- B-18906029350135 EUDAMED
- EMDN Code
- P070402010102 METALLIC NON-STAINLESS STEEL CORONARY STENTS EUDAMED
Classification
- Device Class
- Class III 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
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nexgen™ by Meril Life Sciences Pvt. Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-18906029350135 | Class III | 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 baf8746c-7049-45a5-b3dd-1d9f1dde1712 61 fields · synced Jun 18, 2026
- EUDAMED 3ff99049-8086-4933-ba0a-44a65fa51aa3 61 fields · synced Jun 18, 2026