Identity
- Trade Name
- E-LINK EUDAMEDE-LINK N400 Large Goniometer FDA UDI
- Generic Name
- Electronic goniometer/kinesiology sensor FDA UDI
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMEDAccurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting: Wrist, Forearm, Elbow, Shoulder, Hip, Knee, Ankle, Documentation of amputation, ankylosis, and arthrodesis for the above joints This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- N400 Large Goniometer EUDAMEDN400 FDA UDI
- Description
- Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting: Wrist, Forearm, Elbow, Shoulder, Hip, Knee, Ankle, Documentation of amputation, ankylosis, and arthrodesis for the above joints This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690065 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- ISD FDA UDIKQX FDA UDI
- EMDN Code
- V030202 GONIOMETERS EUDAMED
- GMDN Term
- Electronic goniometer/kinesiology sensor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5360 FDA UDI888.1500 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 d456292f-e81a-4ee8-b721-047f8c6fe793 61 fields · synced Jul 10, 2026
- FDA UDI 55bc5efe-9c76-42a7-819d-dac62432655e 33 fields · synced May 30, 2026