Point Pivot+ - R27L110 - Gunmetal
by Point Designs, LLC United States EUDAMED
Ref ADD-ABD-RAILModel Point Pivot+
EMDN Y061803
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081006742PointPivot+6L | Date6 Dec 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Point Pivot+
- Model / Reference
- Point Pivot+, ADD-ABD-RAIL
- Primary DI / UDI-DI
- 00810067420310
- Basic UDI-DI
- 081006742PointPivot+6L
- EMDN Code
- Y061803 Partial hand prostheses (including fingers prostheses)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000013587
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
From the manufacturer
Manufacturer's product page: Point Pivot+
Other devices from Point Designs, Inc.
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 4fd770ed-64a0-4917-8ed2-b600ef47491d