Emolife
by Gpi S.P.A. Italy EUDAMED
Ref EMOLIFE, EMOLIFE / E-DELPHYN MD
EMDN Z121799
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberIT321284 | Date9 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- IT321284 Supplemented
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 9 May 2025
- Expires
- 22 Feb 2028
- Reason
- Add device or group
- IT321284 Reissued
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 23 Feb 2023
- Expires
- 22 Feb 2028
Specification
- Trade Name
- EmolifeEmolife / E-Delphyn Md
- Model / Reference
- EMOLIFE, EMOLIFE / E-DELPHYN MD
- Primary DI / UDI-DI
- 80589461100338, 80589461100888
- Basic UDI-DI
- 805894611EMOLIFE10MS
- Direct Marketing DI
- 80589461100888
- EMDN Code
- Z121799 Blood transfusion instruments - other
- Device Class
- Class IIb
- Special Device Type
- Software
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000020127
Other devices from Gpi S.P.A.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- 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
Sources (2)
- EUDAMED 0c2f05d5-98a7-4058-917b-84ec4f8c3aaa
- EUDAMED 80589461100888|805894611EMOLIFE10MS