← Back to catalogue
CellaVision® Remote Review Software, Team Edition, version 6.0.x
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CellaVision® Remote Review Software, Team Edition, version 6.0.x FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- The CellaVision remote review software enable up to 5 concurrent 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-TE6099 FDA UDI
- Description
- The CellaVision remote review software enable up to 5 concurrent 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-TE6099 FDA UDI
- Primary DI / UDI-DI
- 07350040974599 FDA UDI
- 510(k) Number
- K102778 FDA UDI
- FDA Product Code
- JOY FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5260 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 Software, Team Edition, version 6.0.x by Cellavision AB — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cellavision AB
Sources (2)
- FDA UDI 5f2fcb94-c0f8-4210-8818-f801e9e7acb6 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026