Dystraktor Podniebienny
by ChM spółka z ograniczoną odpowiedzialnością Poland EUDAMED
Ref 3.4499.032SModel TRANSPALATAL DISTRACTOR EMDN P09120403
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number59084474NSP1VX | Date15 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- IZ 1023642-1 Issued
Technical documentation EU MDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 31 Dec 2025
- Expires
- 30 Dec 2030
Specification
- Device Name
- Dystraktor Podniebienny
- Model / Reference
- TRANSPALATAL DISTRACTOR, 3.4499.032S
- Primary DI / UDI-DI
- 05908447576278
- Basic UDI-DI
- 59084474NSP1VX
- EMDN Code
- P09120403 Osteosynthesis distractors
- Device Class
- Class IIb
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000002121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (1)
- EUDAMED 05908447576278|59084474NSP1VX