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Aerobic/Anaerobic culture bottle (Colorimetric/Fluorescence method)
EUDAMEDClass IVD General (EU MDR)
Ref 30ml, 60.50gModel SC-RA-F
Identity
- Device Name
- Aerobic/Anaerobic culture bottle (Colorimetric/Fluorescence method) EUDAMED
- Model / Reference
- SC-RA-F EUDAMED30ml, 60.50g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897138850111 EUDAMED
- Basic UDI-DI
- B-04897138850111 EUDAMED
- EMDN Code
- W0104010504 BOTTLES FOR AUTOMATED BLOOD CULTURE EUDAMED
Classification
- Device Class
- Class IVD General 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
Aerobic/Anaerobic culture bottle (Colorimetric/Fluorescence method) by Grant Technology (HK) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04897138850111 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Grant Technology (HK) Co., Ltd.
- EUDAMED SRN
- HK-MF-000041730
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 2a72717e-0930-46c8-baea-2942db214d4a 61 fields · synced Oct 6, 2026
- EUDAMED 2a72717e-0930-46c8-baea-2942db214d4a-1 61 fields · synced Jun 9, 2026