Identity
- Trade Name
- Blood Culture Medium EUDAMED
- Device Name
- Blood Culture Medium EUDAMED
- Model / Reference
- 550 04 080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G45855004080WK EUDAMED
- Basic UDI-DI
- ++G458550N8 EUDAMED
- EMDN Code
- W0104010501 BOTTLES FOR MANUAL BLOOD CULTURE 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
No
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
Blood Culture Medium by Spectrum for Diagnostic Industries (Joint Stock Company) — 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 | ++G458550N8 | Class A | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 71f21b60-5ef9-4d20-ae3f-fc089cea21da 61 fields · synced Jun 19, 2026