Identity
- Trade Name
- Chrom MRSA/Blå agarplade EUDAMED
- Device Name
- Selective and differential culture media agar plates / bi-plates EUDAMED
- Model / Reference
- 213429 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712368000190 EUDAMED
- Basic UDI-DI
- 5712368CM_SelDiffA2 EUDAMED
- EMDN Code
- W0104010404 CHROMOGENIC RESISTANCE MARKER MEDIA (PLATES) - MRSA, VRE, ESBL … EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Chrom MRSA/Blå agarplade by SSI Diagnostica A/S — 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 | 5712368CM_SelDiffA2 | Class A | Active |
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Manufacturer
- Manufacturer
- SSI Diagnostica A/S
- EUDAMED SRN
- DK-MF-000023933
Sources (1)
- EUDAMED a65efc7a-c027-4fb8-b165-dffee1dcd922 61 fields · synced Jul 15, 2026