Identity
- Trade Name
- CELUTION EUDAMED
- Device Name
- Celution 805 Consumable Set EUDAMED
- Model / Reference
- Celution 805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974842441106 EUDAMED
- Basic UDI-DI
- 697484244110ME EUDAMED
- EMDN Code
- A0399 TUBULAR DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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 IIb — 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 | 697484244110ME | Class IIb | 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 dc3f8d2c-b839-4cf9-bc30-752a1711eaac 61 fields · synced May 23, 2026