Sterile GIS (gel instillation sonohysterography) Catheter
by Gynétics Medical Products nv
Ref #5165-LN970 GIS Catheter
Active
CE MDR
Valid until
1 Apr 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number540700389GIS0136 05407003890662 | Date1 Sep 2026 | StatusActive |
Certificates
- BE26/00000093 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 1 Apr 2026
- Expires
- 1 Apr 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile GIS (gel instillation sonohysterography) Catheter
- Model / Reference
- #5165-LN970 GIS Catheter
- Primary DI / UDI-DI
- 05407003890662
- Basic UDI-DI
- 540700389GIS0136
- EMDN Code
- U080102 Catheters for hysterosalpingography
- Device Class
- Class I
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000024832
Other devices from Gynétics Medical Products nv
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