Patient warming
by GRI Medical & Electronic Technology Co., Ltd. China EUDAMEDGUDID
Ref 68-480001
Product code KMEEMDN T030399
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number16931918179940 | Date22 May 2023 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number69319181f052RZ | Date10 Aug 2022 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Alleset
- Generic Name
- Operating room turnover kit
- Device Name
- Patient warming
- Model / Reference
- 68-480001
- Primary DI / UDI-DI
- 16931918179940
- Basic UDI-DI
- 69319181f052RZ
- Unit of Use DI
- 06931918179943
- FDA Product Code
- KME
- EMDN Code
- T030399 Heating covers - other
- GMDN Term
- Operating room turnover kit
- Device Class
- Class I
- Regulation Number
- 880.6060
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- CN-MF-000004203
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- Sterile: No
- 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: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 8ec3f9dc-1065-4ffc-b80b-a7ab1cc746b7
- FDA UDI bde8aeca-2be4-44e1-9bbf-4b5182b3f701