ComforTrac Lumbar Traction Device 2.0
by Aspen Medical Products, LLC United States EUDAMED
Ref OLT EMDN Z12130202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081824901TRACTION2R | Date8 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Spinal Traction
- Model / Reference
- OLT
- Primary DI / UDI-DI
- 00818249015965
- Basic UDI-DI
- 081824901TRACTION2R
- EMDN Code
- Z12130202 Traction systems
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000001571
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Aspen Medical Products, LLC
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 f811cc8b-22af-4004-8914-b17f10627b0e