Identity
- Trade Name
- Accel-Heal Solo EUDAMED
- Device Name
- Accel-Heal Solo EUDAMED
- Model / Reference
- K560-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5060276100073R9 EUDAMED
- Basic UDI-DI
- B-5060276100073R9 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Accel-Heal Solo by Accel-Heal Technologies Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-5060276100073R9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Accel-Heal Technologies Limited
- EUDAMED SRN
- GB-MF-000010881
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e5f1250c-db54-4885-b3cc-42812f8ac175 61 fields · synced Jul 10, 2026