Weighted Products
by Fabrication Enterprises United States EUDAMED
Ref 10-0384
EMDN Y0504
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number714905TF04WP3T | Date2 Jan 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Weighted Products
- Model / Reference
- 10-0384
- Primary DI / UDI-DI
- 00714905006639
- Basic UDI-DI
- 714905TF04WP3T
- EMDN Code
- Y0504 Arms, torso and legs re-education devices
- Device Class
- Class I
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 00714905006639|714905TF04WP3T