Identity
- Trade Name
- CureWrap® EUDAMEDCureWrap™ Adult Over 135 cm FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
- Device Name
- CureWraps EUDAMEDAccessory for the CritiCool system. A body wrap connected to the CritiCool. FDA UDI
- Model / Reference
- 500-03500 EUDAMEDFDA UDI
- Description
- Accessory for the CritiCool system. A body wrap connected to the CritiCool. FDA UDI
Identifiers
- Catalog Number
- 500-03500 FDA UDI
- Primary DI / UDI-DI
- 07290012127175 EUDAMEDFDA UDI
- Basic UDI-DI
- 08961280020000128J EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
- GMDN Term
- External circulating-fluid core temperature regulation system control unit, heating/cooling FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: External circulating-fluid core temperature regulation system control unit, heating/cooling
CureWrap™ Adult Over 135 cm by Belmont Instrument Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Belmont Instrument Corp.
Sources (2)
- FDA UDI 330e0aeb-2a51-4b4e-9fb3-311e1be74ed2 34 fields · synced Jul 10, 2026
- EUDAMED 50757abe-e816-45c0-8a00-0fff849b45c5 61 fields · synced Jul 10, 2026