Identity
- Trade Name
- C-Warmer Blue Type 1 EUDAMEDC-Warmer FDA UDI
- Generic Name
- Anaesthesia warmer FDA UDI
- Device Name
- C-Warmer EUDAMEDC-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled cartridge/composite warmer significantly reduces curing time with more flowability of composites and conveniently warms anesthetics and composites in one locations. FDA UDI
- Model / Reference
- CWB1 EUDAMEDBlue Type 1 FDA UDI
- Description
- C-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled cartridge/composite warmer significantly reduces curing time with more flowability of composites and conveniently warms anesthetics and composites in one locations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017900100 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000179WARMERPS EUDAMED
- Direct Marketing DI
- 08800017900100 EUDAMED
- FDA Product Code
- EFC FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Anaesthesia warmer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6100 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
C-Warmer Blue Type 1 by Dxm Co., Ltd — Class I — 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 | 88000179WARMERPS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DXM Co., Ltd.
- EUDAMED SRN
- KR-MF-000016586
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 74b35930-9b22-4088-afaa-9bba68b3bb1f 61 fields · synced Jul 21, 2026
- FDA UDI 825329f4-61e8-427f-82ef-baf5830974a5 34 fields · synced May 30, 2026