Identity
- Trade Name
- SanctbandTM EUDAMED
- Device Name
- Sanctband Balance Cushion EUDAMED
- Model / Reference
- Colour EUDAMEDD010500573-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555514004217 EUDAMED
- Basic UDI-DI
- 955551400BCSH018S EUDAMED
- Direct Marketing DI
- 09555514004217 EUDAMED
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - 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
SanctbandTM by Sanctuary Health Sdn Bhd — 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 | 955551400BCSH018S | Class I | Active |
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Manufacturer
- Manufacturer
- Sanctuary Health Sdn Bhd
- EUDAMED SRN
- MY-MF-000002197
- Authorised Representative
- cosiMed GmbH DE-AR-000016444
Sources (1)
- EUDAMED 14b2a41b-1d35-4425-b72e-1f660d2cc7dd 61 fields · synced Jun 20, 2026