Symphony Oct System
by Medos International SARL EUDAMEDGUDID
Active
Ref 2020-33-102Model SYMPHONY OCT INSTRUMENTS - Dilators
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0705034a002045N | Date17 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10705034532721 | Date1 Jul 2020 | 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- Withdrawn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 24 Oct 2026.
Specification
- Trade Name
- Symphony Oct System EUDAMEDSymphony GUDID
- Generic Name
- Laparoscopic access cannula dilator
- Device Name
- Orthopaedic Surgery Dialators and Retractors - Symphony Oct Instruments
- Model / Ref / Catalog
- SYMPHONY OCT INSTRUMENTS - Dilators, 2020-33-102, 202033102
- Primary DI / UDI-DI
- 10705034532721
- Basic UDI-DI
- 0705034a002045N
- Direct Marketing DI
- 10705034532721
- FDA Product Code
- GEA
- EMDN Code
- L0915 Spreaders and retractors for orthopaedic surgery, reusable
- GMDN Term
- Laparoscopic access cannula dilator
- Device Class
- Class I
- Regulation Number
- 878.4800
- Market of Registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- CH-MF-000014268
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Medos International SARL
Properties
Other properties (20)
- Sterile: No
- Single Use: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No