Codan
by CODAN Medical ApS Denmark EUDAMEDGUDID
Ref 62.7704Model 62.1002
Product code FMFEMDN A020199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number05706225001147 | Date7 Feb 2024 | StatusWithdrawn |
| European Union | CE/MDR EUDAMED | Number5706225Klasse1SGJ | Date16 Feb 2023 | StatusWithdrawn |
Coverage
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Codan EUDAMEDCODAN Luer-Lock 20 ml GUDID
- Generic Name
- General-purpose syringe, single-use
- Device Name
- 1 ML CODAN PRIMO TBC Luer Centrisk Clear Sterile
- Model / Reference
- 62.1002, 62.7704
- Primary DI / UDI-DI
- 05706225001147
- Basic UDI-DI
- 5706225Klasse1SGJ
- 510(k) Number
- FDA Product Code
- FMF
- EMDN Code
- A020199 Syringes, single-use - other
- GMDN Term
- General-purpose syringe, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 880.5860
- Market of Registration
- Denmark
- Commercial Distribution
- Not in Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- DK-MF-000001269
Other devices from Codan Medical ApS
Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 045e447d-4ed7-43d1-bf9b-509b9a1953c0
- FDA UDI d6fea25c-b399-4cde-bf3d-7150d65e40e3