Identity
- Trade Name
- DataLOG EUDAMEDDataLOG MWX8 FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- Data Acquisition Products EUDAMEDThe DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection and monitoring in human performance, sports science, medical research, industrial ergonomics, gait laboratories, and educational settings. Includes: 8 channel data acquisition unit, Bluetooth adapter, 6 x Micro SD cards, Card reader, Management Software, instrument case This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- MWX8 DataLOG EUDAMEDMWX8 FDA UDI
- Description
- The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection and monitoring in human performance, sports science, medical research, industrial ergonomics, gait laboratories, and educational settings. Includes: 8 channel data acquisition unit, Bluetooth adapter, 6 x Micro SD cards, Card reader, Management Software, instrument case This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Catalog Number
- MWX8 DataLOG - plastic connectors FDA UDI
- Primary DI / UDI-DI
- 05060481691666 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169DataAcqProdAD EUDAMED
- FDA Product Code
- KQX FDA UDIIKK FDA UDI
- EMDN Code
- Z120605,Z120617 EUDAMED
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1500 FDA UDI890.1925 FDA UDI
- Market of Registration
- Northern Ireland 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
No
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
Yes
FDA UDI
DataLOG by Biometrics Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506048169DataAcqProdAD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biometrics Ltd
- EUDAMED SRN
- GB-MF-000002774
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 6d72d224-95ca-4647-8cb0-3bc4be31c8bb 61 fields · synced Jun 19, 2026
- FDA UDI df5a2e94-b1f4-4f8c-86d5-4eef4fa2044d 34 fields · synced May 29, 2026