Heated bed for newborns and infants VL-22
by ALFAMEDIC s.r.o. 16 variants
Ref VL-22F-S-OModel VL-22 / VL-22F
Active
CE MDR
Valid until
3 Jun 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number859420147VL22F001MT 08594201470042 | Date24 Jun 2025 | StatusActive |
Certificates
- 2025-MDR/QS-031 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 3 Jun 2025
- Expires
- 3 Jun 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Heated bed for newborns and infants
- Model / Reference
- VL-22 / VL-22F, VL-22F-S-O
- Primary DI / UDI-DI
- 08594201470042
- Basic UDI-DI
- 859420147VL22F001MT
- Direct Marketing DI
- 08594201470042
- EMDN Code
- Z12080407 Neonatal radiant warmers
- Device Class
- Class IIb
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000037764
Other devices from ALFAMEDIC s.r.o.
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No