Identity
- Trade Name
- CHCA Matrix for use with AUTOF MS EUDAMED
- Model / Reference
- Autof EUDAMEDMSA03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359510943 EUDAMED
- Basic UDI-DI
- 697015090000060H2 EUDAMED
- EMDN Code
- W0104030403 IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
CHCA Matrix for use with AUTOF MS by Autobio Diagnostics Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697015090000060H2 | Class A | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 19fb15cb-8616-42de-afde-5a05c12dadb2 61 fields · synced Jul 20, 2026