G-Walk
by BTS S.p.A. Italy EUDAMEDGUDID
Ref GSN2Model G-Walk
Product code HCCEMDN Z12062502
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++B179GS2QR | Date14 Jun 2024 | StatusActive |
| United States | GUDID listing GUDID | NumberB179GSN2 | Date6 Jul 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- G-Walk EUDAMEDG-Sensor GUDID
- Generic Name
- Gait analysis system
- Device Name
- GSensor 2
- Model / Ref / Catalog
- G-Walk EUDAMEDGSN2 EUDAMED2 GUDIDBTSGSN2 GUDID
- Primary DI / UDI-DI
- B179GSN2
- Basic UDI-DI
- ++B179GS2QR
- FDA Product Code
- HCC
- EMDN Code
- Z12062502 Kinematic inertial motion capture analysis systems
- GMDN Term
- Gait analysis system
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 882.5050
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | G-Walk GSN2 | 2 |
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- IT-MF-000041044
Other devices from BTS S.p.A.
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- Sterile: No
- Single Use: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 96387927-be5a-4e89-9d46-431566befd85
- FDA UDI 647d6b47-eccc-4579-8fc2-576629960f1b