Identity
- Trade Name
- CareGuard EUDAMED
- Device Name
- CareGUARD Sterilisation Wraps EUDAMED
- Model / Reference
- SW13713750-B/B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19332017001878 EUDAMED
- Basic UDI-DI
- 09332017CGSWGV EUDAMED
- Direct Marketing DI
- 19332017001878 EUDAMED
- EMDN Code
- S010302 NON-WOVEN FABRIC FOR STERILISATION EUDAMED
Classification
- Device Class
- Class I 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
CareGuard by Care Essentials Pty Ltd — 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 | 09332017CGSWGV | Class I | Active |
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Manufacturer
- Manufacturer
- Care Essentials Pty Ltd
- EUDAMED SRN
- AU-MF-000009150
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 0f45993b-4fe0-42aa-b7a7-f56d57d0d035 61 fields · synced May 20, 2026