Elevate Encompass
by Total Gym Commercial LLC EUDAMED
Active
Ref 5200E1ORB2Model 5200-B2
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G2065200SERIESVB | Date14 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Elevate Encompass
- Model / Reference
- 5200-B2, 5200E1ORB2
- Primary DI / UDI-DI
- ++G20655200E1ORB21N
- Basic UDI-DI
- ++G2065200SERIESVB
- EMDN Code
- Z120602 Physiotherapy equipment
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000019351
- Authorised representative
- Total Gym Europe B.V. NL-AR-000013843
From the manufacturer
Manufacturer's product page: Encompass
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