Dentálny implantát MTI
by MARTIKAN s.r.o. EUDAMED
Active
Ref MTI U05, MTI E08, MTI E06, MTI E01, MTI E07, MTI U10, MTI U02, MTI L04, MTI E05, MTI E02, MTI L01, MTI E14, MTI U01, MTI E09, MTI E13, MTI E04, MTI L05, MTI L02, MTI U04Model MTI
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2022-MDR/QS-003/A | Date10 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2022-MDR/QS-003/A Supplemented
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 10 Apr 2026
- Expires
- 20 Jul 2027
- Reason
- Other
- 2022-MDR/TD-003/A Supplemented
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 10 Apr 2026
- Expires
- 20 Jul 2027
- Reason
- Other
Specification
- Device Name
- Dentálny implantát
- Model / Reference
- MTI, MTI U05, MTI E08, MTI E06, MTI E01, MTI E07, MTI U10, MTI U02, MTI L04, MTI E05, MTI E02, MTI L01, MTI E14, MTI U01, MTI E09, MTI E13, MTI E04, MTI L05, MTI L02, MTI U04
- Primary DI / UDI-DI
- 08586023520517, 08586023520340, 08586023520326, 08586023520272, 08586023520333, 08586023520562, 08586023520487, 08586023520449, 08586023520319, 08586023520289, 08586023520418, 08586023520401, 08586023520470, 08586023520357, 08586023520395, 08586023520302, 08586023520456, 08586023520425, 08586023520500
- Basic UDI-DI
- 858602352MTIRL
- EMDN Code
- P01020101 Dental implants
- Device Class
- Class IIb
- Market of Registration
- Slovakia
Manufacturer details
- EUDAMED SRN
- SK-MF-000005834
Other devices from MARTIKAN s.r.o.
Properties
Other properties (13)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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