Identity
- Trade Name
- DataLITE EUDAMEDDataLITE DG2 Wireless Dongle FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- Data Acquisition Products EUDAMEDA small wireless Dongle (receiver) attached to the USB port of the host PC (Windows 8 or 10 compatible) can communicate with up to 24 channels of DataLITE sensor inputs via Wi-Fi. When used with a Windows 10 Tablet, the researcher can monitor and analyse data in real-time while the subject has total freedom of movement in laboratory or field studies.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- DG2 DataLITE PIONEER EUDAMEDDG2 FDA UDI
- Description
- A small wireless Dongle (receiver) attached to the USB port of the host PC (Windows 8 or 10 compatible) can communicate with up to 24 channels of DataLITE sensor inputs via Wi-Fi. When used with a Windows 10 Tablet, the researcher can monitor and analyse data in real-time while the subject has total freedom of movement in laboratory or field studies.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690607 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169DataAcqProdAD EUDAMED
- FDA Product Code
- KQX FDA UDIHCC FDA UDIIKK FDA UDI
- EMDN Code
- Z120605,Z120617 EUDAMED
- GMDN Term
- Medical networking interface unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1500 FDA UDI882.5050 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
DataLITE 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 a45e1d54-108b-4a0f-ad92-5961c8dd300d 61 fields · synced Jul 29, 2026
- FDA UDI 49960910-b628-4951-a73d-74f1df2eba71 33 fields · synced May 30, 2026