← Back to catalogue
Automated Digital Cell Morphology Analyzer DI-60
EUDAMEDFDA UDIClass A (EU MDR)
Ref CC286297
Identity
- Trade Name
- Automated Digital Cell Morphology Analyzer DI-60 EUDAMEDAutomated Digital Morphology Analyzer DI-60 FDA UDI
- Generic Name
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
- Device Name
- Automated Digital Cell Morphology Analyzer DI-60 EUDAMEDAutomated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears FDA UDI
- Model / Reference
- CC286297 EUDAMEDFDA UDI
- Description
- Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears FDA UDI
Identifiers
- Catalog Number
- CC286297 FDA UDI
- Primary DI / UDI-DI
- 07350040972021 EUDAMEDFDA UDI
- Basic UDI-DI
- 735004097CC286297T7 EUDAMED
- Direct Marketing DI
- 07350040972021 EUDAMED
- 510(k) Number
- K092868 FDA UDI
- FDA Product Code
- GKZ FDA UDIJOY FDA UDI
- EMDN Code
- W02029099 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI864.5260 FDA UDI
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Automated Digital Cell Morphology Analyzer DI-60 by Cellavision AB — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 735004097CC286297T7 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CellaVision AB
- EUDAMED SRN
- SE-MF-000002377
Sources (2)
- EUDAMED e5fd8af1-a1c6-4a6a-a7d9-d63995f93e7c 61 fields · synced Jun 20, 2026
- FDA UDI 94bd167b-12d7-4bdb-8171-db4ac2542d1a 36 fields · synced May 29, 2026