Identity
- Trade Name
- Sabouraud Dextrose Agar EUDAMED
- Device Name
- Sabouraud Dextrose Agar EUDAMED
- Model / Reference
- 639 01 100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G45863901100MP EUDAMED
- Basic UDI-DI
- ++G45863901N5 EUDAMED
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) 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
Sabouraud Dextrose Agar 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 | ++G45863901N5 | Class A | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 597b45bf-2d72-4892-adc1-c6c8075f63ba 61 fields · synced Jun 19, 2026