Identity
- Trade Name
- E-LINK EUDAMEDE-LINK X4 Interface Unit FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMEDThe X4 InterX Unit functions as the intelligent interface to connect the E-LINK evaluation and exercise modules to the computer via the USB port. Up to four E-LINK devices may be connected simultaneously allowing the user to easily and quickly switch between them during an evaluation or exercise session. Includes Medical Grade Power Supply and country specific mains power cord. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013. FDA UDI
- Model / Reference
- X4 InterX Unit EUDAMEDX4 FDA UDI
- Description
- The X4 InterX Unit functions as the intelligent interface to connect the E-LINK evaluation and exercise modules to the computer via the USB port. Up to four E-LINK devices may be connected simultaneously allowing the user to easily and quickly switch between them during an evaluation or exercise session. Includes Medical Grade Power Supply and country specific mains power cord. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013. FDA UDI
Identifiers
- Catalog Number
- X4 MkIV plastic connectors FDA UDI
- Primary DI / UDI-DI
- 05060481690003 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- HCC FDA UDIISD 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
- 882.5050 FDA UDI890.5360 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 3125e4d7-e80e-4607-850b-e6b2380fb936 61 fields · synced Aug 2, 2026
- FDA UDI 4405dfee-dd97-4afa-a35c-9ded1898e697 34 fields · synced May 25, 2026