Identity
- Trade Name
- Allcheck COVID-19 Ag EUDAMED
- Device Name
- Allcheck COVID-19 Ag EUDAMED
- Model / Reference
- CHR11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800061800425 EUDAMED
- Basic UDI-DI
- B-08800061800425 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Allcheck COVID-19 Ag by CALTH Inc. — 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-08800061800425 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CALTH Inc.
- EUDAMED SRN
- KR-MF-000044697
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 6e3588bc-d04d-42ea-8c80-7af0d13380f5 61 fields · synced Jul 10, 2026
- EUDAMED 3944ab4c-e01f-423d-916e-3c3b9133ad3c 61 fields · synced Jul 10, 2026