← Back to catalogue
Positive Blood Cultures Pretreatment Reagent
EUDAMEDClass A (EU MDR)
Ref MSA04Model Autof
Identity
- Trade Name
- Positive Blood Cultures Pretreatment Reagent EUDAMED
- Model / Reference
- Autof EUDAMEDMSA04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150907907 EUDAMED
- Basic UDI-DI
- 697015090000061H4 EUDAMED
- EMDN Code
- W0104010501 BOTTLES FOR MANUAL BLOOD CULTURE 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
Positive Blood Cultures 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 | 697015090000061H4 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 8b30277e-2e35-4662-ac0d-a4d4c6556474 61 fields · synced Aug 4, 2026