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AlloSeq Tx 9
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref ASTX9.1(96)-B-IVDModel AlloSeq Tx 9(96) Set BRef ASTX9.1(96)-A-IVDModel AlloSeq Tx 9(96) Set A
Identity
- Device Name
- AlloSeq Tx 9 EUDAMED
- Model / Reference
- AlloSeq Tx 9(96) Set B EUDAMEDASTX9.1(96)-B-IVD EUDAMEDAlloSeq Tx 9(96) Set A EUDAMEDASTX9.1(96)-A-IVD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19358706000069 EUDAMED19358706000052 EUDAMED
- Basic UDI-DI
- B-19358706000069 EUDAMEDB-19358706000052 EUDAMED
- EMDN Code
- W01030403 HLA ANTIGEN TYPING EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: HLA class I & II antigen tissue typing IVD, kit, multiplex
AlloSeq Tx 9 by CareDx Pty Ltd — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-19358706000069 | Class IVD Annex II List B | 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 a4ca6d23-1d2a-48e6-9a09-1a7bfc2d171d 61 fields · synced Jul 9, 2026
- EUDAMED d98c399f-633c-46ba-bb3e-fd0a834e98a0 61 fields · synced May 19, 2026