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CellaVision® Remote Review Enterprise Edition License upgrade from Group to Ent…
EUDAMEDFDA UDIClass A (EU MDR)
Ref CRRS-ENGR99
Identity
- Trade Name
- CellaVision® Remote Review Enterprise Edition License upgrade from Group to Enterprise Edition EUDAMEDCellaVision® Remote Review Software, Enterprise upgrade from Group Ed. FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- CellaVision® Review Software EUDAMEDThe CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location. FDA UDI
- Model / Reference
- CRRS-ENGR99 EUDAMEDFDA UDI
- Description
- The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location. FDA UDI
Identifiers
- Catalog Number
- CRRS-GRGR99 FDA UDI
- Primary DI / UDI-DI
- 07350040974544 EUDAMEDFDA UDI
- Basic UDI-DI
- 735004097CRRSB5 EUDAMED
- 510(k) Number
- K092868 FDA UDI
- FDA Product Code
- JOY FDA UDI
- EMDN Code
- W02029092 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5260 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CellaVision® Remote Review Enterprise Edition License upgrade from Group to Ent… by Cellavision AB — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 735004097CRRSB5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- CellaVision AB
- EUDAMED SRN
- SE-MF-000002377
Sources (2)
- EUDAMED 96a64069-aa2c-45e0-9dc6-4dce0b5c5d87 61 fields · synced Jul 12, 2026
- FDA UDI 438eaeff-5c9d-48e0-9b6a-3c75e07bf227 36 fields · synced May 30, 2026