Identity
- Trade Name
- Sample Pretreatment Reagent EUDAMED
- Model / Reference
- Autof EUDAMEDMSA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150908249 EUDAMED
- Basic UDI-DI
- 697015090000058HF EUDAMED
- EMDN Code
- W0104030403 IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Sample Pretreatment Reagent 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 | 697015090000058HF | 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 f1960503-2bdd-42e0-a456-ff2d6aa82c46 61 fields · synced Jun 18, 2026