ReSolve®, StayFIX®,
by Merit Medical Systems, Inc.
Ref RLCMB-NV-12-SFXModel A
Active
CE MDD
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/MDD | NumberB-00884450014875 00884450014875 | Date19 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- A, RLCMB-NV-12-SFX
- Primary DI / UDI-DI
- 00884450014875
- Basic UDI-DI
- B-00884450014875
- EMDN Code
- A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000001366
- Authorised representative
- Merit Medical Ireland Ltd IE-AR-000001011
Other devices from Merit Medical Systems, Inc.
Properties
Other properties (11)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No