Identity
- Device Name
- AlloSeq HCT EUDAMEDAlloSeq HCT Software EUDAMED
- Model / Reference
- ASHCT.1(96)-IVD EUDAMEDASHCTS2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19358706000106 EUDAMED19358706000113 EUDAMED
- Basic UDI-DI
- B-19358706000106 EUDAMEDB-19358706000113 EUDAMED
- EMDN Code
- W0106010499 POLYMORPHISM TESTS - OTHER EUDAMEDV92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
AlloSeq HCT by CareDx Pty Ltd — 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-19358706000106 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CareDx Pty Ltd
- EUDAMED SRN
- AU-MF-000046711
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED a95367a1-5156-4fe3-9f56-3c68d4a14c74 61 fields · synced Jul 28, 2026
- EUDAMED f56616d1-ed0e-4e4c-ba75-9a2b569af9c7 61 fields · synced May 18, 2026