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Aerobic culture bottle SA
EUDAMEDClass A (EU MDR)
Ref MC0307Model Automated Blood Culture system， Microbial Detection System，Automated Microbial Detection SystemRef MC0304
Identity
- Trade Name
- Aerobic culture bottle SA EUDAMED
- Device Name
- Aerobic culture bottle SA EUDAMED
- Model / Reference
- Automated Blood Culture system， Microbial Detection System，Automated Microbial Detection System EUDAMEDMC0307 EUDAMEDMC0304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359525787 EUDAMED06970150909383 EUDAMED
- Basic UDI-DI
- 697015090000138HE 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
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Aerobic culture bottle SA 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 | 697015090000138HE | 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 (2)
- EUDAMED 22657d9b-4374-4174-b2b2-0f41dfdd8cdf 61 fields · synced Jul 9, 2026
- EUDAMED 31691ec4-af27-49c9-b9ae-e5b352f746c1 61 fields · synced May 18, 2026