lumetry
Ref LUM-01
Active
CE MDR
Valid until
8 Oct 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR-0053 | Date9 Oct 2026 | StatusActive |
Certificates
- MDR-0053 Active
Quality management system EU MDR
- Certifier
- SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304
- Issued
- 9 Oct 2026
- Expires
- 8 Oct 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- LUM-01
- Primary DI / UDI-DI
- 09120138350011
- Basic UDI-DI
- 912013835LUM015D
- Direct Marketing DI
- 09120138350011
- EMDN Code
- Z12159099 Various pneumology and respiratory physiopathology instruments - other
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000047369
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