Identity
- Device Name
- SCORE 6 EUDAMED
- Model / Reference
- 303.701-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340035519003 EUDAMED
- Basic UDI-DI
- B-07340035519003 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Score 6 by CareDx AB — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-07340035519003 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CareDx AB
- EUDAMED SRN
- SE-MF-000040995
Sources (1)
- EUDAMED 727f7331-cafd-49b9-8a42-3f6412c44054 61 fields · synced Jul 14, 2026