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Cocoon Convective Warming System - CWS 4000
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref CWS4000-220Model CWS 4000
Identity
- Trade Name
- Cocoon Convective Warming System - CWS 4000 EUDAMED
- Device Name
- Convective Patient Warming Machine EUDAMED
- Model / Reference
- CWS 4000 EUDAMEDCWS4000-220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09332017004063 EUDAMED
- Basic UDI-DI
- 09332017CWS4H9 EUDAMED
- Direct Marketing DI
- 09332017004063 EUDAMED
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria 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
Cocoon Convective Warming System - CWS 4000 by Care Essentials Pty Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140635 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K181671 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 09332017CWS4H9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Care Essentials Pty Ltd
- EUDAMED SRN
- AU-MF-000009150
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED c94dd701-e5db-4740-a373-3a8bfb95843e 61 fields · synced Jul 9, 2026
- FDA 510(k) K140635 1 fields · synced May 18, 2026