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Immuno-Chromogenic Reagent
EUDAMEDClass A (EU MDR)
Ref IFCP0010Ref IFCP0011Ref IFCP0001Ref IFCP0006Ref IFYC0042Ref IFYC0041Ref IFYC0043Ref IFCP0012Ref IFYC0040
Identity
- Device Name
- Immuno-Chromogenic Reagent EUDAMED
- Model / Reference
- IFCP0010 EUDAMEDIFCP0011 EUDAMEDIFCP0001 EUDAMEDIFCP0006 EUDAMEDIFYC0042 EUDAMEDIFYC0041 EUDAMEDIFYC0043 EUDAMEDIFCP0012 EUDAMEDIFYC0040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979822870198 EUDAMED06979822870303 EUDAMED06979822870044 EUDAMED06979822870143 EUDAMED06979822870068 EUDAMED06979822870150 EUDAMED06979822870341 EUDAMED06979822870204 EUDAMED06979822870280 EUDAMED06979822870327 EUDAMED06979822870136 EUDAMED
- Basic UDI-DI
- 697982287IFCP0010C8 EUDAMED697982287IFCPAVL EUDAMED697982287IFCP0001C7 EUDAMED697982287IFCP0006CH EUDAMED697982287IFYC0042H4 EUDAMED697982287IFYC0041H2 EUDAMED697982287IFCP0011CA EUDAMED697982287IFYC0043H6 EUDAMED697982287IFYC0040GY 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
No
EUDAMEDEUDAMED
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 | 697982287IFCP0010C8 | 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 (11)
- EUDAMED 02602af5-7fb3-40b4-a7d8-52e4f1bf8f07 61 fields · synced Aug 1, 2026
- EUDAMED 321bd61b-4963-4e00-994e-eed2419d3255 61 fields · synced May 16, 2026
- EUDAMED d3429caa-553a-42b9-be92-c545f72398aa 61 fields · synced May 16, 2026
- EUDAMED 4a909f39-b41e-4773-98da-6807c54fb722 61 fields · synced May 17, 2026
- EUDAMED d66e830e-33e0-47f2-8190-7849d73069dd 61 fields · synced May 17, 2026
- EUDAMED 31e5bf11-c5ca-4a8f-a14b-d3bab817974e 61 fields · synced May 17, 2026
- EUDAMED 15d55660-3508-46a8-98fd-78b71468a850 61 fields · synced May 17, 2026
- EUDAMED 0546c447-750d-4162-bb00-8ab8cc4a8d73 61 fields · synced May 17, 2026
- EUDAMED 056e399a-cdef-4a33-bbb4-35769a8649fa 61 fields · synced May 17, 2026
- EUDAMED 7cbfc506-d7cd-44ab-bb3c-906090886d5a 61 fields · synced May 18, 2026
- EUDAMED f7ec14b7-570f-44cb-bdaa-ffdd8bfe3374 61 fields · synced May 19, 2026