Identity
- Trade Name
- CellaVision® DC-1 EUDAMEDCellaVision DC-1 FDA UDI
- Generic Name
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
- Device Name
- CellaVision® DC-1 EUDAMED
- Model / Reference
- XU-10301 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350040975091 EUDAMEDFDA UDI
- Basic UDI-DI
- 735004097XU-10301AH EUDAMED
- Direct Marketing DI
- 07350040975091 EUDAMED
- 510(k) Number
- K200595 FDA UDI
- FDA Product Code
- JOY 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
- 864.5260 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
CellaVision® DC-1 by Cellavision AB — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200595 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 735004097XU-10301AH | Class A | Active |
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Manufacturer
- Manufacturer
- CellaVision AB
- EUDAMED SRN
- SE-MF-000002377
Sources (3)
- EUDAMED bbf3641b-f7ba-46c6-8c36-526dc7e1f309 61 fields · synced Jul 9, 2026
- FDA UDI ef9f9dad-d723-4c3f-8dac-528bf0af693d 33 fields · synced May 29, 2026
- FDA 510(k) K200595 1 fields · synced Jun 9, 2026