Identity
- Trade Name
- Combo Plus EUDAMED
- Device Name
- Combo Plus Dual Therapy Stent EUDAMED
- Model / Reference
- Ø 3.0 x 9 mm EUDAMED230-092-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717853297441 EUDAMED
- Basic UDI-DI
- B-08717853297441 EUDAMED
- EMDN Code
- P0704020102 COATED CORONARY STENTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Combo Plus by OrbusNeich Medical, B.V. — 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-08717853297441 | Class III | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical, B.V.
- EUDAMED SRN
- NL-MF-000010907
Sources (1)
- EUDAMED 25fcc1b4-ac01-4812-9bf4-a1c858f663a6 61 fields · synced Jun 17, 2026