2.5 TriLock Dist.Rad.FramePl Volar Right
by Medartis AG EUDAMEDGUDID
Active
Ref A-4750.34S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number76300378020P6 | Date25 Mar 2025 | StatusActive |
| United States | GUDID listing GUDID | Number07630037890508 | Date3 Nov 2024 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Trade Name
- 2.5 TriLock Dist.Rad.FramePl Volar Right EUDAMEDAptus GUDID
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable
- Device Name
- Bone plates (sterile, non-sterile)
- Model / Ref / Catalog
- A-4750.34S EUDAMEDA-4750.33S GUDID
- Primary DI / UDI-DI
- 07630037890508
- Basic UDI-DI
- 76300378020P6
- 510(k) Number
- FDA Product Code
- HRS
- EMDN Code
- P09120599 Bone fixation plates - other
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 888.3030
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | A-4750.34S | A-4750.33S |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CH-MF-000022291
- Authorised representative
- Medartis GmbH DE-AR-000005810
Other devices from Medartis AG
Properties
Other properties (17)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No