Identity
- Trade Name
- DAPI Antifade ES EUDAMED
- Device Name
- DAPI Antifade ES EUDAMED
- Model / Reference
- CE-DES 500L EUDAMEDCE-DES 1000L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055844935037 EUDAMED05055844907300 EUDAMED05055844907294 EUDAMED05055844935044 EUDAMED
- Basic UDI-DI
- 50558449DESWT EUDAMED
- EMDN Code
- W01030703 DNA IN SITU HYBRIDISATION REAGENTS 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
Yes
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
DAPI Antifade ES by Cytocell Limited — 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 | 50558449DESWT | Class A | Active |
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Manufacturer
- Manufacturer
- Cytocell Limited
- EUDAMED SRN
- GB-MF-000016893
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (4)
- EUDAMED 911e0534-d941-4a3c-b801-f28ea09c1cae 61 fields · synced Aug 2, 2026
- EUDAMED b5673404-0df4-4421-bc56-d0790dbcadc0 61 fields · synced May 17, 2026
- EUDAMED e3cc730b-57b1-4262-a1a0-42f5e37481cc 61 fields · synced May 17, 2026
- EUDAMED 97d2f5e4-2303-44d1-8198-4c9bc044fd8c 61 fields · synced May 19, 2026