Firefly Phototherapy
by Medical Technology Transfer and Services Company Limited Vietnam EUDAMED
Ref FF1-1000Model Firefly Phototherapy
EMDN Z12080401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberPP11684FIREFLY30 | Date2 Feb 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2024-MDR/QS-002 Supplemented
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 19 Jan 2024
- Expires
- 19 Jan 2029
- Reason
- Other
Specification
- Device Name
- Infant Phototherapy Device
- Model / Reference
- Firefly Phototherapy, FF1-1000
- Primary DI / UDI-DI
- 111720641527
- Basic UDI-DI
- PP11684FIREFLY30
- Direct Marketing DI
- 111720641527
- EMDN Code
- Z12080401 Paediatric phototherapy equipment
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- VN-MF-000036669
- Authorised representative
- Logic S.r.l. IT-AR-000012301
From the manufacturer
Manufacturer's product page: Firefly Phototherapy
Other devices from Medical Technology Transfer and Services Company Limited
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 (1)
- EUDAMED 20c6c632-db83-433b-8710-fb6032bf04ae