Identity
- Trade Name
- Scoreflex PTA EUDAMEDScoreflex PTA Scoring Balloon Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Scoreflex PTA Balloon Dilatation Catheter EUDAMEDCatheter, Percutaneous, Cutting/Scoring FDA UDI
- Model / Reference
- BM640-404C EUDAMEDBM640-404CU FDA UDI
- Description
- Catheter, Percutaneous, Cutting/Scoring FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934955941160 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06934955941160 EUDAMED
- FDA Product Code
- PNO FDA UDILIT FDA UDI
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Balloon Diameter — 4.0 Millimeter FDA UDICatheter Length — 90 Centimeter FDA UDIGuidewire Diameter — 0.018 Inch FDA UDIBalloon Length — 40 Millimeter FDA UDI
Scoreflex PTA by OrbusNeich Medical (Shenzhen) Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934955941160 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- OrbusNeich Medical (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000011345
- Authorised Representative
- Quality First International OÜ EE-AR-000004308
Sources (2)
- EUDAMED aad4ff3c-bc16-465c-a447-a71fa9f2144e 61 fields · synced Jul 10, 2026
- FDA UDI 8d4089b9-4fce-4728-943f-4f6f3448ba8a 36 fields · synced May 30, 2026