Banding Tubing Stretch Products
by Fabrication Enterprises 852 variants
Ref 10-3220-10
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number714905TF02BTZP 00714905000552 | Date2 Jan 2024 | 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- Withdrawn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
- Banding Tubing Stretch Products
- Model / Reference
- 10-3220-10
- Primary DI / UDI-DI
- 00714905000552
- Basic UDI-DI
- 714905TF02BTZP
- Unit of Use DI
- 00714905003638
- EMDN Code
- Y0504 Arms, torso and legs re-education devices
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000014521
- Authorised representative
- AJW Technology Consulting GmbH DE-AR-000004999
Other devices from Fabrication Enterprises
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