Lumina 3D-e
by Karel Hrnčíř - BIOMAG 3 variants
Ref LUMINA 3D-e EA, LUMINA 3D-e CAModel BIOMAG® Lumina 3D-e s aplikátory
Active
CE MDR
Valid until
31 Jan 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2024-MDR/QS-001/A | Date30 May 2026 | StatusActive |
Certificates
- 2024-MDR/QS-001/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 30 May 2026
- Expires
- 31 Jan 2029
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Pulsed Magnetic Therapy Device BIOMAG®
- Model / Reference
- BIOMAG® Lumina 3D-e s aplikátory, LUMINA 3D-e EA, LUMINA 3D-e CA
- Primary DI / UDI-DI
- 08594208280019, 08594208280033
- Basic UDI-DI
- 859420828BIOMAGLUMINA3DSA
- EMDN Code
- Z120606 Magnetotherapy equipment
- Device Class
- Class IIa
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000025009
Other devices from Karel Hrnčíř - BIOMAG
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