BIONIKA TH, Fejcsavar, technikai
by BIONIKA Medline Kft. EUDAMED
Active
Ref 626.082.014.000
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number599322001SV | Date20 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Dental laboratory devices, Class I.
- Model / Reference
- 626.082.014.000
- Primary DI / UDI-DI
- 05993220862952
- Basic UDI-DI
- 599322001SV
- EMDN Code
- Q010280 Prosthetic dentistry devices - accessories
- Device Class
- Class I
- Market of Registration
- Hungary
Manufacturer details
- EUDAMED SRN
- HU-MF-000004631
Other devices from BIONIKA Medline Kft.
Properties
Other properties (12)
- Sterile: No
- Implantable: 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