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Integrated Film Processing and Colorization Machine
EUDAMEDClass A (EU MDR)
Ref ZRCP0001Model CellStainer 100
Identity
- Device Name
- Integrated Film Processing and Colorization Machine EUDAMED
- Model / Reference
- CellStainer 100 EUDAMEDZRCP0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979822870242 EUDAMED
- Basic UDI-DI
- 697982287ZRCP0001UN EUDAMED
- EMDN Code
- W02029099 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER 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
Yes
EUDAMED
New Device
Yes
EUDAMED
Integrated Film Processing and Colorization Machine 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 | 697982287ZRCP0001UN | 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 e4e00d48-5b66-4cac-805c-abe1c66af604 61 fields · synced Jun 19, 2026