LifeVac Standard Kit
Ref LV01
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5065007352LVBA 05065007352007 | Date1 Aug 2025 | 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- Withdrawn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
- LifeVac
- Model / Reference
- LV01
- Primary DI / UDI-DI
- 05065007352007
- Basic UDI-DI
- 5065007352LVBA
- Direct Marketing DI
- 05065007352007
- EMDN Code
- R0599 Respiratory devices, suction and dilation systems - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- GB-MF-000010279
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from LifeVac Europe Limited
Properties
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