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baiobit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref BAIOBITModel G-WalkRef BAIOBITCModel BAIOBIT-C
by Bts Spa
Identity
- Trade Name
- baiobit EUDAMEDFDA UDI
- Generic Name
- Gait analysis system FDA UDI
- Device Name
- GSensor 2 EUDAMEDBAIOBIT-C EUDAMEDBAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional movement analysis. FDA UDI
- Model / Reference
- G-Walk EUDAMEDBAIOBIT EUDAMEDBAIOBIT-C EUDAMEDBAIOBITC EUDAMED1 FDA UDI
- Description
- BAIOBIT is a wireless system consisting of an inertial sensor composed by a tri-axial accelerometer, a magnetic sensor, and a tri-axial gyroscope, that worn by the patient allows a functional movement analysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B179BAIO1 EUDAMEDFDA UDIB179BAIOBITC0 EUDAMED
- Basic UDI-DI
- ++B179GS2QR EUDAMED++B179BAIOBITCTH EUDAMED
- Direct Marketing DI
- B179BAIO1 EUDAMEDB179BAIOBITC0 EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- Z12062502 KINEMATIC INERTIAL MOTION CAPTURE ANALYSIS SYSTEMS EUDAMEDN010299 NEUROLOGIC PHYSIOTHERAPHY DEVICES - OTHER EUDAMED
- GMDN Term
- Gait analysis system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gait analysis system
baiobit by Bts Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bts Spa
Sources (3)
- FDA UDI dc85782e-1009-4206-a29c-3d271d14d03b 33 fields · synced Jul 16, 2026
- EUDAMED 33746043-8245-4672-8bf2-18b2404e6ee5 61 fields · synced Jul 16, 2026
- EUDAMED 19413397-e62d-479b-bcc3-df18453aee13 61 fields · synced Jul 16, 2026