Identity
- Trade Name
- E-LINK EUDAMEDE-LINK DG1 Wireless Dongle FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMEDThe wireless Dongle (DG1) enables E-LINK to be used as a complete stand-alone wireless evaluation and exercise system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- DG1 Wireless Dongle EUDAMEDDG1 FDA UDI
- Description
- The wireless Dongle (DG1) enables E-LINK to be used as a complete stand-alone wireless evaluation and exercise system.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690195 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- ISD FDA UDIBXB FDA UDIION FDA UDI
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Medical networking interface unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5360 FDA UDI890.5380 FDA UDI890.5370 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
E-Link 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 | 506048169E-LINKY3 | 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 17843621-2b6c-4cb8-86f4-0ac6275bf487 61 fields · synced Jun 8, 2026
- FDA UDI 2135afc7-310a-43e7-a551-41660e3c92c6 33 fields · synced May 30, 2026