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CellaVision® Advanced RBC Application DM1200 Non-Expiring License
EUDAMEDFDA UDIClass A (EU MDR)
Ref CAR-120099
Identity
- Trade Name
- CellaVision® Advanced RBC Application DM1200 Non-Expiring License EUDAMEDCellaVision® Advanced RBC Application DM1200 FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- CellaVision® Advanced RBC Application EUDAMEDWhen implemented together with CellaVision DM1200 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics FDA UDI
- Model / Reference
- CAR-120099 EUDAMEDFDA UDI
- Description
- When implemented together with CellaVision DM1200 and software, the CellaVision Advanced RBC Application speeds up and simplifies the review process while delivering more standardized results. The application support RBC Differential by delivering a comprehensive pre-characterization based on 21 morphological characteristics FDA UDI
Identifiers
- Catalog Number
- CAR-120099 FDA UDI
- Primary DI / UDI-DI
- 07350040973745 EUDAMEDFDA UDI
- Basic UDI-DI
- 735004097CAREZ EUDAMED
- 510(k) Number
- K171315 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® Advanced RBC Application DM1200 Non-Expiring License 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 | 735004097CAREZ | 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 99cd363e-cdf2-4b41-8fed-f7293ba893f3 61 fields · synced Jul 11, 2026
- FDA UDI 3f6c4fa8-2894-4426-828d-9aa9cff74f3d 36 fields · synced May 30, 2026