Identity
- Trade Name
- Balance Active EUDAMED
- Device Name
- Accessories EUDAMED
- Model / Reference
- EXYO-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060783170005 EUDAMED
- Basic UDI-DI
- 50562352POSTURESYSACC4F EUDAMED
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Balance Active by Jenx Limited — Class I — 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 | 50562352POSTURESYSACC4F | Class I | Active |
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Manufacturer
- Manufacturer
- Jenx Limited
- EUDAMED SRN
- GB-MF-000016540
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5bf5340f-1ce6-4358-b8dc-919967d6404a 61 fields · synced Jun 18, 2026