Identity
- Trade Name
- VISITECT EUDAMED
- Device Name
- VISITECT® CD4 Advanced Disease EUDAMED
- Model / Reference
- AB376 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15061002300019 EUDAMED
- Basic UDI-DI
- B-15061002300019 EUDAMED
- EMDN Code
- W0103080106 ANTIBODIES FOR LYMPHOCYTE SUBTYPING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Visitect by AccuBio Limited — 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-15061002300019 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- AccuBio Limited
- EUDAMED SRN
- UK-MF-000041152
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED faf3a8c3-fca0-4348-8d8a-efed5b7e2572 61 fields · synced Jun 18, 2026