Identity
- Trade Name
- Combo Plus EUDAMED
- Device Name
- Combo Plus Dual Therapy Stent EUDAMED
- Model / Reference
- Ø 2.5 x 28 mm EUDAMED225-282-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717853297359 EUDAMED
- Basic UDI-DI
- B-08717853297359 EUDAMED
- EMDN Code
- P070402010301 CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS 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
Yes
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-08717853297359 | Class III | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical, B.V.
- EUDAMED SRN
- NL-MF-000010907
Sources (1)
- EUDAMED 38e753c1-7383-476b-a1c1-7004bbe89075 61 fields · synced Jun 19, 2026