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Cled agar with Bromothymol Blue
EUDAMEDClass A (EU MDR)
Ref 612 01 100Ref 612 01 500
Identity
- Trade Name
- Cled agar with Bromothymol Blue EUDAMED
- Device Name
- Cled agar with Bromothymol Blue EUDAMED
- Model / Reference
- 612 01 100 EUDAMED612 01 500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G45861201100AH EUDAMEDG45861201500WH EUDAMED
- Basic UDI-DI
- ++G45861201LL 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
Cled agar with Bromothymol Blue 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 | ++G45861201LL | Class A | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 7fd1fda5-db02-41ee-93d9-7aa37ac2b333 61 fields · synced Oct 6, 2026
- EUDAMED 8f429b8e-2233-499f-9e4d-0940acd1178c 61 fields · synced May 17, 2026