Identity
- Trade Name
- CELUTION EUDAMED
- Device Name
- Celution 800 Cell Processing Device EUDAMED
- Model / Reference
- Celution 800.CRS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974842440109 EUDAMED
- Basic UDI-DI
- 697484244010M9 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Celution by Cytori Therapeutics LLC. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697484244010M9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cytori Therapeutics LLC.
- EUDAMED SRN
- CN-MF-000012840
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED bf70b3b3-cab1-470d-8d83-10619b36c218 61 fields · synced May 23, 2026