← Back to catalogue
Mycobacterial Culture Bottle
EUDAMEDClass C (EU MDR)
Ref MC0401Model Automated Blood Culture system/Microbial Detection SystemRef MC0402
Identity
- Trade Name
- Mycobacterial Culture Bottle EUDAMED
- Model / Reference
- Automated Blood Culture system/Microbial Detection System EUDAMEDMC0401 EUDAMEDMC0402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150909949 EUDAMED06970150907563 EUDAMED
- Basic UDI-DI
- 697015090000063H8 EUDAMED
- EMDN Code
- W0104010603 AUTOMATED MYCOBACTERIA MEDIA (BOTTLES) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Belgium 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
Mycobacterial Culture Bottle by Autobio Diagnostics Co., Ltd. — Class C — 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 | 697015090000063H8 | Class C | 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 (2)
- EUDAMED 4810d9d8-5212-4d8a-af88-e84f1aa81fbe 61 fields · synced Jul 9, 2026
- EUDAMED 0f2ff7c0-f3e7-4053-9cb0-11e67dfc8a0b 61 fields · synced May 17, 2026