AtmosAir Velaris
by ArjoHuntleigh AB 363 variants
Ref 633044CYModel 120PM000/000
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
An overview of the AtmosAir Velaris medical device, including its features and regulatory compliance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5060693520174W9 05059441180920 | Date19 Jul 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Pentaflex
- Model / reference
- 120PM000/000, 633044CY
- Primary DI / UDI-DI
- 05059441180920
- Basic UDI-DI
- 5060693520174W9
- EMDN code
- V080702 Non active anti-decubitus medical mattresses
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Cyprus
Manufacturer details
- EUDAMED SRN
- SE-MF-000000696
Other devices from Arjohuntleigh AB
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No