Identity
- Trade Name
- MaCconkey Agar EUDAMED
- Device Name
- MaCconkey Agar EUDAMED
- Model / Reference
- 618 01 100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G45861801100KN EUDAMED
- Basic UDI-DI
- ++G45861801MJ 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
MaCconkey 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 | ++G45861801MJ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 73c32891-086b-4359-a0ce-5a9fa1cb009e 61 fields · synced Oct 6, 2026