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Scoreflex NC
EUDAMEDClass III (EU MDD (legacy))
Ref 622-154-1Model Ø 2.25 x 15 mm
Identity
- Trade Name
- Scoreflex NC EUDAMED
- Generic Name
- PTCA BALLOON DILATION CATHETERS EUDAMED
- Device Name
- Scoreflex NC EUDAMED
- Model / Reference
- Ø 2.25 x 15 mm EUDAMED622-154-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719244950072 EUDAMED
- Basic UDI-DI
- B-08719244950072 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Legislation / Framework
- MDD (Directive 93/42/EEC on Medical Devices) EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Scoreflex NC by OrbusNeich Medical, B.V. (ptca balloon dilation catheters) — 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-08719244950072 | Class III | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical, B.V.
- EUDAMED SRN
- NL-MF-000010907
Sources (1)
- EUDAMED 68 fields · synced Jun 9, 2026