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Scoreflex PTA
EUDAMEDClass IIa (EU MDR)
Ref 650F-20B-31Model Ø 5.0 x 20 mmRef 620F-40X-31Model Ø 2.0 x 40 mmRef 630F-15N-31Model Ø 3.0 x 15 mmRef 645E-40B-31Model Ø 4.5 x 40 mmRef 625F-20B-31Model Ø 2.5 x 20 mmRef 640E-20A-31Model Ø 4.0 x 20 mmRef 630F-20X-31Model Ø 3.0 x 20 mmRef 620E-40X-31Ref 635F-40B-31Model Ø 3.5 x 40 mmRef 660E-15X-31Model Ø 6.0 x 15 mmRef 625E-20B-31Ref 625-153-1Model Ø 2.5 x 15mmRef 625-103-1Model Ø 2.5 x 10mmRef 635E-15X-31Model Ø 3.5 x 15 mmRef 625F-20X-31Ref 660F-20A-31Model Ø 6.0 x 20 mmRef 655F-20X-31Model Ø 5.5 x 20 mmRef 635F-15X-31Ref 635F-20B-31Model Ø 3.5 x 20 mmRef 625F-15X-31Model Ø 2.5 x 15 mmRef 650E-20A-31Ref 625-203-1Ref 620F-20X-31Model Ø 2.0 x 20 mmRef 650E-15X-31Model Ø 5.0 x 15 mmRef 620F-20B-31Ref 655E-20X-31Ref 635-103-1Model Ø 3.5 x 10 mmRef 625F-40B-31Model Ø 2.5 x 40 mmRef 640E-40X-31Model Ø 4.0 x 40 mmRef 630F-15X-31Ref 640F-20X-31Ref 640-103-1Model Ø 4.0 x 10 mmRef 635-203-1Ref 650E-20B-31Ref 660E-20B-31Ref 650F-20X-31Ref 650E-40A-31Model Ø 5.0 x 40 mmRef 635E-20B-31Ref 620-153-1Model Ø 2.0 x 15mmRef 660E-20X-31Ref 640E-20B-31Ref 660F-40B-31Model Ø 6.0 x 40 mmRef 655E-40B-31Model Ø 5.5 x 40 mmRef 640-153-1Model Ø 4.0 x 15 mmRef 625F-15N-31Ref 660F-20B-31Ref 650F-20A-31Ref 645F-20X-31Model Ø 4.5 x 20 mmRef 660E-40A-31Ref 655F-40X-31Ref 640F-20A-31
Identity
- Trade Name
- Scoreflex PTA EUDAMEDScoreflex EUDAMED
- Device Name
- Scoreflex PTA EUDAMEDScoreflex PTA Balloon Dilatation Catheter EUDAMEDScoreflex EUDAMED
- Model / Reference
- Ø 5.0 x 20 mm EUDAMED650F-20B-31 EUDAMEDØ 2.0 x 40 mm EUDAMED620F-40X-31 EUDAMEDØ 3.0 x 15 mm EUDAMED630F-15N-31 EUDAMEDØ 4.5 x 40 mm EUDAMED645E-40B-31 EUDAMEDØ 2.5 x 20 mm EUDAMED625F-20B-31 EUDAMEDØ 4.0 x 20 mm EUDAMED640E-20A-31 EUDAMEDØ 3.0 x 20 mm EUDAMED630F-20X-31 EUDAMED620E-40X-31 EUDAMEDØ 3.5 x 40 mm EUDAMED635F-40B-31 EUDAMEDØ 6.0 x 15 mm EUDAMED660E-15X-31 EUDAMED625E-20B-31 EUDAMEDØ 2.5 x 15mm EUDAMED625-153-1 EUDAMEDØ 2.5 x 10mm EUDAMED625-103-1 EUDAMEDØ 3.5 x 15 mm EUDAMED635E-15X-31 EUDAMED625F-20X-31 EUDAMEDØ 6.0 x 20 mm EUDAMED660F-20A-31 EUDAMEDØ 5.5 x 20 mm EUDAMED655F-20X-31 EUDAMED635F-15X-31 EUDAMEDØ 3.5 x 20 mm EUDAMED635F-20B-31 EUDAMEDØ 2.5 x 15 mm EUDAMED625F-15X-31 EUDAMED650E-20A-31 EUDAMED625-203-1 EUDAMEDØ 2.0 x 20 mm EUDAMED620F-20X-31 EUDAMEDØ 5.0 x 15 mm EUDAMED650E-15X-31 EUDAMED620F-20B-31 EUDAMED655E-20X-31 EUDAMEDØ 3.5 x 10 mm EUDAMED635-103-1 EUDAMEDØ 2.5 x 40 mm EUDAMED625F-40B-31 EUDAMEDØ 4.0 x 40 mm EUDAMED640E-40X-31 EUDAMED630F-15X-31 EUDAMED640F-20X-31 EUDAMEDØ 4.0 x 10 mm EUDAMED640-103-1 EUDAMED635-203-1 EUDAMED650E-20B-31 EUDAMED660E-20B-31 EUDAMED650F-20X-31 EUDAMEDØ 5.0 x 40 mm EUDAMED650E-40A-31 EUDAMED635E-20B-31 EUDAMEDØ 2.0 x 15mm EUDAMED620-153-1 EUDAMED660E-20X-31 EUDAMED640E-20B-31 EUDAMEDØ 6.0 x 40 mm EUDAMED660F-40B-31 EUDAMEDØ 5.5 x 40 mm EUDAMED655E-40B-31 EUDAMEDØ 4.0 x 15 mm EUDAMED640-153-1 EUDAMED625F-15N-31 EUDAMED660F-20B-31 EUDAMED650F-20A-31 EUDAMEDØ 4.5 x 20 mm EUDAMED645F-20X-31 EUDAMED660E-40A-31 EUDAMED655F-40X-31 EUDAMED640F-20A-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717853298226 EUDAMED08717853297724 EUDAMED08717853297816 EUDAMED08717853298721 EUDAMED08717853298127 EUDAMED08717853298790 EUDAMED08717853297823 EUDAMED08717853298363 EUDAMED08717853298172 EUDAMED08717853298585 EUDAMED08717853298639 EUDAMED08717853292422 EUDAMED08717853292415 EUDAMED08717853298431 EUDAMED08717853297762 EUDAMED08717853298325 EUDAMED08717853298059 EUDAMED08717853297861 EUDAMED08717853298165 EUDAMED08717853297748 EUDAMED08717853298813 EUDAMED08717853292439 EUDAMED08717853297700 EUDAMED08717853298523 EUDAMED08717853298103 EUDAMED08717853298561 EUDAMED08717853292477 EUDAMED08717853298134 EUDAMED08717853298486 EUDAMED08717853297809 EUDAMED08717853297946 EUDAMED08717853292507 EUDAMED08717853292491 EUDAMED08717853298738 EUDAMED08717853298776 EUDAMED08717853298028 EUDAMED08717853298820 EUDAMED08717853298677 EUDAMED08717853292392 EUDAMED08717853298592 EUDAMED08717853298691 EUDAMED08717853298271 EUDAMED08717853298769 EUDAMED08717853292514 EUDAMED08717853297755 EUDAMED08717853298264 EUDAMED08717853298301 EUDAMED08717853297991 EUDAMED08717853298844 EUDAMED08717853298066 EUDAMED08717853298288 EUDAMED
- Basic UDI-DI
- B-08717853298226 EUDAMEDB-08717853297724 EUDAMEDB-08717853297816 EUDAMEDB-08717853298721 EUDAMEDB-08717853298127 EUDAMEDB-08717853298790 EUDAMEDB-08717853297823 EUDAMEDB-08717853298363 EUDAMEDB-08717853298172 EUDAMEDB-08717853298585 EUDAMEDB-08717853298639 EUDAMEDB-08717853292422 EUDAMEDB-08717853292415 EUDAMEDB-08717853298431 EUDAMEDB-08717853297762 EUDAMEDB-08717853298325 EUDAMEDB-08717853298059 EUDAMEDB-08717853297861 EUDAMEDB-08717853298165 EUDAMEDB-08717853297748 EUDAMEDB-08717853298813 EUDAMEDB-08717853292439 EUDAMEDB-08717853297700 EUDAMEDB-08717853298523 EUDAMEDB-08717853298103 EUDAMEDB-08717853298561 EUDAMEDB-08717853292477 EUDAMEDB-08717853298134 EUDAMEDB-08717853298486 EUDAMEDB-08717853297809 EUDAMEDB-08717853297946 EUDAMEDB-08717853292507 EUDAMEDB-08717853292491 EUDAMEDB-08717853298738 EUDAMEDB-08717853298776 EUDAMEDB-08717853298028 EUDAMEDB-08717853298820 EUDAMEDB-08717853298677 EUDAMEDB-08717853292392 EUDAMEDB-08717853298592 EUDAMEDB-08717853298691 EUDAMEDB-08717853298271 EUDAMEDB-08717853298769 EUDAMEDB-08717853292514 EUDAMEDB-08717853297755 EUDAMEDB-08717853298264 EUDAMEDB-08717853298301 EUDAMEDB-08717853297991 EUDAMEDB-08717853298844 EUDAMEDB-08717853298066 EUDAMEDB-08717853298288 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMEDC010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass III EUDAMED
- Market of Registration
- Denmark EUDAMEDItaly EUDAMEDGermany 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
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Also classified as Peripheral angioplasty balloon catheter, basic.
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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-08717853298226 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical, B.V.
- EUDAMED SRN
- NL-MF-000010907
Sources (51)
- EUDAMED 01163d76-eab4-4fa5-b1ae-4253c7fcc956 61 fields · synced Oct 6, 2026
- EUDAMED b048a05b-7231-431e-a8d6-180f479b3503 61 fields · synced May 16, 2026
- EUDAMED ff348b7f-befe-4ded-b1cc-397031382ff6 61 fields · synced May 16, 2026
- EUDAMED 5377d9fb-b1a3-447e-bb4a-20e045227e1c 61 fields · synced May 16, 2026
- EUDAMED 5973744f-8f12-4486-97bd-c6908be58711 61 fields · synced May 16, 2026
- EUDAMED a032bd60-08aa-42fd-961e-3414ea85591b 61 fields · synced May 16, 2026
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- EUDAMED 48f7bb61-480a-417e-be98-8aee937daa23 61 fields · synced May 17, 2026
- EUDAMED 5bde4ef1-045e-4774-9221-7e5843bf6fe6 61 fields · synced May 17, 2026
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- EUDAMED 458aa95c-e538-4a87-89b9-356070e1a07d 61 fields · synced May 17, 2026
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- EUDAMED e736b58b-142e-44b3-b314-23e697a66906 61 fields · synced May 17, 2026
- EUDAMED d3c22a3b-8ed3-4062-b8d6-1d5227d77658 61 fields · synced May 17, 2026
- EUDAMED 3a9913ba-005b-4cbc-b0dd-92fa650b7678 61 fields · synced May 18, 2026
- EUDAMED fca9fabe-aad4-461a-8be7-90683d815fed 61 fields · synced May 18, 2026
- EUDAMED da31af6c-009f-463c-aa40-f024ec861e41 61 fields · synced May 18, 2026
- EUDAMED 989dae17-48be-45b5-bd09-32f023c1df28 61 fields · synced May 18, 2026
- EUDAMED 1c656758-aba5-4ef1-8b1d-50863c647d93 61 fields · synced May 18, 2026
- EUDAMED 228fe05b-3a32-438c-b009-572af822d865 61 fields · synced May 18, 2026
- EUDAMED 9d8a97df-cc1c-4899-942b-6969833bad8a 61 fields · synced May 18, 2026
- EUDAMED fd96a732-97fa-4188-96d3-db51a92a4f34 61 fields · synced May 18, 2026
- EUDAMED 47a7fdd4-b50c-4f77-9bc3-a1dab8ea3ae9 61 fields · synced May 18, 2026
- EUDAMED 269bbe71-120e-4225-b149-486e63ab7418 61 fields · synced May 18, 2026
- EUDAMED 7f2aa14b-b73f-42d0-9b43-4068ef1dbac6 61 fields · synced May 18, 2026
- EUDAMED 58bdd233-9554-48bb-af95-12e157658b13 61 fields · synced May 18, 2026
- EUDAMED fb8bfd4f-5f7d-4ae6-afcc-eabea92ddab6 61 fields · synced May 18, 2026