Pulse Brown FR 32-6
by Alps South, LLC United States EUDAMED
Ref CLBNFR32-6 EMDN Y062499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number07139801000102475 | Date10 Feb 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Tenax & Pulse Liner
- Model / Reference
- CLBNFR32-6
- Primary DI / UDI-DI
- 00713980038641
- Basic UDI-DI
- 07139801000102475
- EMDN Code
- Y062499 Lower extremity prostheses - other
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- US-MF-000001260
- Authorised representative
- AR Experts B.V. NL-AR-000023989
Other devices from Alps South, 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 00713980038641|07139801000102475