Identity
- Trade Name
- CellaVision® DM9600 EUDAMEDFDA UDI
- Generic Name
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
- Device Name
- CellaVision® DM9600 EUDAMEDAutomated cell locating device. DM9600 automatically locates and presents images of blood cells on peripherall blood smears. FDA UDI
- Model / Reference
- XU-10288-01 EUDAMEDFDA UDI
- Description
- Automated cell locating device. DM9600 automatically locates and presents images of blood cells on peripherall blood smears. FDA UDI
Identifiers
- Catalog Number
- XU-10288-01 FDA UDI
- Primary DI / UDI-DI
- 07350040974322 EUDAMEDFDA UDI
- Basic UDI-DI
- 735004097XU-10288BJ EUDAMED
- Direct Marketing DI
- 07350040974322 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
CellaVision® DM9600 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 | 735004097XU-10288BJ | 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 a16fd629-99b4-4ee3-8c9c-af6b04332650 61 fields · synced Jun 18, 2026
- FDA UDI 285e1306-ead8-4f61-ab8c-b1a745a3c846 36 fields · synced May 30, 2026