Identity
- Trade Name
- Kenex 1701/10 Sandbag EUDAMED
- Device Name
- Kenex Sandbag EUDAMED
- Model / Reference
- 1701/02 8x24cm EUDAMED1701/10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055449416481 EUDAMED
- Basic UDI-DI
- 50554494SBPX7 EUDAMED
- Direct Marketing DI
- 05055449416481 EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I 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
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
Kenex 1701/10 Sandbag by Kenex (electro-Medical) 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 | 50554494SBPX7 | Class I | Active |
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Manufacturer
- Manufacturer
- Kenex (Electro-Medical) Limited
- EUDAMED SRN
- GB-MF-000009022
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 6d0c1cc9-3e68-4814-8720-dd0ceedab4c2 61 fields · synced Jul 16, 2026