Identity
- Trade Name
- Hall-U-Sana EUDAMED
- Device Name
- Continuous Passive Motion Device EUDAMED
- Model / Reference
- HA-500.100L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640255020366 EUDAMED
- Basic UDI-DI
- 764025502Hall-U-Sana4N EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Hall-U-Sana by Effectum Medical AG — 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 | 764025502Hall-U-Sana4N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Effectum Medical AG
- EUDAMED SRN
- CH-MF-000012474
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (1)
- EUDAMED 19222ff4-fe78-40c3-b13a-c6b553960f0b 61 fields · synced Oct 6, 2026