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by tic Medizintechnik GmbH Germany EUDAMED
Ref ti1012Model PremiumLINE
EMDN Z12062799
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426021766-T-PLSH | Date4 Feb 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- syntic
- Model / Reference
- PremiumLINE, ti1012
- Primary DI / UDI-DI
- 04260217666222
- Basic UDI-DI
- 426021766-T-PLSH
- Direct Marketing DI
- 04260217666222
- EMDN Code
- Z12062799 Functional electrical stimulation systems - other
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000033923
Other devices from tic Medizintechnik GmbH
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED c2f2c4c4-71c6-47ae-9f40-0bfc2e964f4f