Identity
- Trade Name
- Tryptic soy agar EUDAMED
- Device Name
- Tryptic soy agar EUDAMED
- Model / Reference
- 645 01 100 EUDAMED645 01 500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G458645011004L EUDAMEDG45864501500QL EUDAMED
- Basic UDI-DI
- ++G4586450100WS 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
Tryptic soy 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 | ++G4586450100WS | Class A | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED b6d61efd-d398-47e6-9474-9f3a38369cae 61 fields · synced Oct 6, 2026
- EUDAMED 134ca9f7-2d68-48fb-8905-dd01ec15a7a8 61 fields · synced May 17, 2026