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Scoreflex NC
EUDAMEDClass III (EU MDR)
Ref 617-104-1Model Ø 1.75 x 10 mmRef 635-154-1Model Ø 3.5 x 15 mmRef 620-104-1Model Ø 2.0 x 10 mmRef 627-154-1Model Ø 2.75 x 15 mmRef 620-204-1Model Ø 2.0 x 20 mmRef 622-104-1Model Ø 2.25 x 10 mmRef 640-204-1Model Ø 4.0 x 20 mmRef 640-104-1Model Ø 4.0 x 10 mmRef 640-154-1Model 4.0 x 15 mmRef 625-204-1Model Ø 2.5 x 20 mmRef 617-204-1Model Ø 1.75 x 20 mmRef 630-154-1Model Ø 3.0 x 15 mmRef 617-154-1Model Ø 1.75 x 15 mmRef 630-104-1Model Ø 3.0 x 10 mm
Identity
- Trade Name
- Scoreflex NC EUDAMED
- Device Name
- Scoreflex NC EUDAMED
- Model / Reference
- Ø 1.75 x 10 mm EUDAMED617-104-1 EUDAMEDØ 3.5 x 15 mm EUDAMED635-154-1 EUDAMEDØ 2.0 x 10 mm EUDAMED620-104-1 EUDAMEDØ 2.75 x 15 mm EUDAMED627-154-1 EUDAMEDØ 2.0 x 20 mm EUDAMED620-204-1 EUDAMEDØ 2.25 x 10 mm EUDAMED622-104-1 EUDAMEDØ 4.0 x 20 mm EUDAMED640-204-1 EUDAMEDØ 4.0 x 10 mm EUDAMED640-104-1 EUDAMED4.0 x 15 mm EUDAMED640-154-1 EUDAMEDØ 2.5 x 20 mm EUDAMED625-204-1 EUDAMEDØ 1.75 x 20 mm EUDAMED617-204-1 EUDAMEDØ 3.0 x 15 mm EUDAMED630-154-1 EUDAMEDØ 1.75 x 15 mm EUDAMED617-154-1 EUDAMEDØ 3.0 x 10 mm EUDAMED630-104-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719244950003 EUDAMED08719244950195 EUDAMED08719244950034 EUDAMED08719244950133 EUDAMED08719244950058 EUDAMED08719244950065 EUDAMED08719244950232 EUDAMED08719244950218 EUDAMED08719244950225 EUDAMED08719244950119 EUDAMED08719244950027 EUDAMED08719244950164 EUDAMED08719244950010 EUDAMED08719244950157 EUDAMED
- Basic UDI-DI
- B-08719244950003 EUDAMEDB-08719244950195 EUDAMEDB-08719244950034 EUDAMEDB-08719244950133 EUDAMEDB-08719244950058 EUDAMEDB-08719244950065 EUDAMEDB-08719244950232 EUDAMEDB-08719244950218 EUDAMEDB-08719244950225 EUDAMEDB-08719244950119 EUDAMEDB-08719244950027 EUDAMEDB-08719244950164 EUDAMEDB-08719244950010 EUDAMEDB-08719244950157 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III 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
Category: Coronary angioplasty balloon catheter, cutting/scoring
Scoreflex NC by OrbusNeich Medical, B.V. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08719244950003 | Class III | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical, B.V.
- EUDAMED SRN
- NL-MF-000010907
Sources (14)
- EUDAMED 3b358e29-f89c-46cf-8ff6-a5d3cd5fb849 61 fields · synced Oct 6, 2026
- EUDAMED ed72ea4c-bb25-4338-a069-d1c4f3941643 61 fields · synced May 11, 2026
- EUDAMED 239e61a6-7e10-4426-9d5a-45339b576f19 61 fields · synced Jul 8, 2026
- EUDAMED f17490c8-43b0-4556-bbd9-da8f481d7837 61 fields · synced Jul 9, 2026
- EUDAMED 7aec3e3b-5778-455d-87ec-f124725714de 61 fields · synced Jul 10, 2026
- EUDAMED adfda92d-6e51-4423-8075-ea9342d270a8 61 fields · synced Jul 10, 2026
- EUDAMED 105c1c31-8e25-490d-ad9d-2aeb349031a6 61 fields · synced Jul 12, 2026
- EUDAMED 45811d12-9275-4864-b066-0d4860c369df 61 fields · synced Jul 12, 2026
- EUDAMED e2fe24c4-59b3-4270-ae94-476a424fd950 61 fields · synced Jul 14, 2026
- EUDAMED 785264ce-1213-4f56-8491-2d4bd84ba5ac 61 fields · synced Jul 15, 2026
- EUDAMED 8a2e0cb2-fcfe-4690-b484-4bd997519bf0 61 fields · synced Jul 24, 2026
- EUDAMED 22c64666-3d8f-4647-979d-19a970d3fba4 61 fields · synced Jul 26, 2026
- EUDAMED 0261b6e9-4f4c-4230-b5da-3d6bf125b106 61 fields · synced Aug 3, 2026
- EUDAMED eb1f4b41-769c-42c2-8755-e20e330c5087 61 fields · synced Sep 17, 2026