Identity
- Trade Name
- E-LINK EUDAMEDE-LINK N300 Small 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. Hand (fingers and thumb) – active and passive, extension and flexion, abduction and adduction, lateral deviations and rotational deformities, calculation of total active motion and total passive motion Wrist – active and passive, extension and flexion, radial and ulnar deviation This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- N300 Small Goniometer EUDAMEDN300 FDA UDI
- Description
- Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. Hand (fingers and thumb) – active and passive, extension and flexion, abduction and adduction, lateral deviations and rotational deformities, calculation of total active motion and total passive motion Wrist – active and passive, extension and flexion, radial and ulnar deviation This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690058 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- KQX FDA UDIISD FDA UDI
- EMDN Code
- V030202 GONIOMETERS EUDAMED
- GMDN Term
- Electronic goniometer/kinesiology sensor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.1500 FDA UDI890.5360 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 84ef7845-6a0a-4494-b003-08b0b2bc22d8 61 fields · synced May 29, 2026
- FDA UDI 635e65a9-946b-40e0-b6eb-3752ebe996c4 33 fields · synced May 26, 2026