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Allcheck Influenza A+B
EUDAMEDClass IVD General (EU MDR)
Ref CHR08
by CALTH Inc.
Identity
- Trade Name
- Allcheck Influenza A+B EUDAMED
- Device Name
- Allcheck Influenza A+B EUDAMED
- Model / Reference
- CHR08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800061800470 EUDAMED
- Basic UDI-DI
- B-08800061800470 EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Allcheck Influenza A+B 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-08800061800470 | 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 (1)
- EUDAMED a0e9ff76-bb4f-491e-880b-bb3e8d54012c 61 fields · synced Jul 17, 2026