Identity
- Trade Name
- Scoreflex PTA EUDAMED
- Device Name
- Scoreflex PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- Ø 2.0 x 40 mm EUDAMED620E-40B-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717853298622 EUDAMED
- Basic UDI-DI
- B-08717853298622 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Category: Peripheral angioplasty balloon catheter, basic
Scoreflex PTA by OrbusNeich Medical, B.V. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
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- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
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-08717853298622 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical, B.V.
- EUDAMED SRN
- NL-MF-000010907
Sources (1)
- EUDAMED 7d18baf6-b2d9-4f8f-9f52-e6b8c5b1f1a7 61 fields · synced Jun 9, 2026