Identity
- Device Name
- CellAED EUDAMED
- Model / Reference
- CellAED 2.2 EUDAMED100-2.2-094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09357138000008 EUDAMED
- Basic UDI-DI
- B-09357138000008 EUDAMED
- EMDN Code
- Z12030503 AUTOMATIC DEFIBRILLATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CellAED by RRR Manufacturing Pty Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09357138000008 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RRR Manufacturing Pty Ltd
- EUDAMED SRN
- AU-MF-000034615
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 748a3929-53e8-4486-8599-3b128c33aa94 61 fields · synced Jun 18, 2026