Scoreflex PTA
by OrbusNeich Medical (Shenzhen) Co., Ltd 115 variants
Ref AL640-154C
Scoreflex PTA (AL640-154C) is a device classified as Class IIa in the EU and Class II in the US made by OrbusNeich Medical (Shenzhen) Co., Ltd, registered in EUDAMED on 14 Apr 2026 (Basic UDI-DI B-06934955922374) and listed in FDA GUDID since 1 Oct 2019 (UDI-DI 06934955922374), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06934955922374 06934955922374 | Date14 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06934955922374 | Date1 Oct 2019 | StatusListed |
Official records
- EUDAMED public site B-06934955922374
- AccessGUDID record 06934955922374
Across registries
- EUDAMED Basic UDI-DI B-06934955922374 registered 14 Apr 2026 Active
- FDA GUDID UDI-DI 06934955922374 listed 1 Oct 2019 Listed
Timeline
- Listed FDA GUDID 06934955922374
- Registered EUDAMED B-06934955922374
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Scoreflex PTA EUDAMEDScoreflex PTA Scoring Balloon Catheter GUDID
- Generic name
- Peripheral angioplasty balloon catheter, basic
- Device name
- Scoreflex PTA Balloon Dilatation Catheter
- Model / reference
- AL640-154C EUDAMEDAL640-154CU GUDID
- Primary DI / UDI-DI
- 06934955922374
- Basic UDI-DI
- B-06934955922374
- FDA product code
- LIT, PNO
- EMDN code
- C010402020101 PTA balloon dilatation catheters
- GMDN term
- Peripheral angioplasty balloon catheter, basic
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 870.1250
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Size
- Balloon Diameter — 4.0 MillimeterBalloon Length — 15 MillimeterGuidewire Diameter — 0.014 InchCatheter Length — 150 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | AL640-154C | AL640-154CU |
| Device class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000011345
- Authorised representative
- Quality First International OÜ EE-AR-000004308
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