Identity
- Device Name
- Immuno-Chromogenic Reagent EUDAMED
- Model / Reference
- IFCP0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979822870297 EUDAMED
- Basic UDI-DI
- 697982287IFCPAVL EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) 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
Immuno-Chromogenic Reagent by Cellomics (Shenzhen) 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 | 697982287IFCPAVL | Class A | Active |
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Manufacturer
- Manufacturer
- Cellomics (Shenzhen) Limited
- EUDAMED SRN
- CN-MF-000028334
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ba6a668c-e103-44ff-8c9c-6293880f85f3 61 fields · synced Jun 19, 2026