Identity
- Trade Name
- Cocoon EUDAMEDFDA UDI
- Generic Name
- Circulating-air whole-body heating system control unit FDA UDI
- Device Name
- Convective Patient Warming Machine EUDAMEDCocoon Warming Machine FDA UDI
- Model / Reference
- CWS 5000 EUDAMEDFDA UDI
- Description
- Cocoon Warming Machine FDA UDI
Identifiers
- Catalog Number
- CWS5000-110 FDA UDI
- Primary DI / UDI-DI
- 09332017002007 EUDAMEDFDA UDI
- Basic UDI-DI
- 09332017CWS5HB EUDAMED
- Direct Marketing DI
- 09332017002007 EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
- GMDN Term
- Circulating-air whole-body heating system control unit FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cocoon by Care Essentials Pty Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 09332017CWS5HB | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 b01ed1d0-87a0-4d12-90d5-3a3f21f8b7f0 61 fields · synced Jul 10, 2026
- FDA UDI 4b73a45e-5125-4452-9874-3eda3d249114 35 fields · synced May 30, 2026