Hygion
Ref FIX-K-3Model FIX-K,EZLOCK,Securefix,Catheter Securement Device
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6975284211002AB 06975284210275 | Date15 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- sterile I.V. Cannula and Catheter Fixation Dressing
- Model / Reference
- FIX-K, EZLOCK, Securefix, Catheter Securement Device, FIX-K-3
- Primary DI / UDI-DI
- 06975284210275
- Basic UDI-DI
- 6975284211002AB
- Direct Marketing DI
- 06975284210275
- EMDN Code
- M04010201 Non-woven fixing dressings
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000008239
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Hony Medical Co., Ltd.
Properties
Other properties (12)
- 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