Identity
- Device Name
- SAP by Curas™ EUDAMED
- Model / Reference
- 08102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051400081026 EUDAMED
- Basic UDI-DI
- 5051400SAP01BOTXXZN EUDAMED
- EMDN Code
- T0499 INCONTINENCE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia 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
SAP by Curas™ by Curas 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 | 5051400SAP01BOTXXZN | Class I | Active |
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Manufacturer
- Manufacturer
- Curas Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000036883
- Authorised Representative
- Kabomed GmbH AT-AR-000007569
Sources (1)
- EUDAMED b37c4c01-b76e-4181-8229-55218c0079a4 61 fields · synced Jul 16, 2026