Magnetic Waist Support
Ref 715-TAN-F-1
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
A medical device designed for the treatment of spine orthotheses. The Magnetic Waist Support is an implantable device that provides support and stability to patients undergoing spinal surgery.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471988489CL104GN 04719884896468 | Date4 Sep 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Spine Orthoses
- Model / Reference
- 715-TAN-F-1
- Primary DI / UDI-DI
- 04719884896468
- Basic UDI-DI
- 471988489CL104GN
- EMDN Code
- Y060399 Spine orthoses - other
- Device Class
- Class I
- EU market of registration
- Malta
Manufacturer details
- EUDAMED SRN
- TW-MF-000005197
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Welsheng Corp.
Properties
Other properties (13)
- Sterile: No
- 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