Identity
- Trade Name
- E-LINK EUDAMEDE-LINK Software (Version 16) FDA UDI
- Generic Name
- Biomechanical function analysis/rehabilitation software FDA UDI
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMEDE-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities. E-LINK is available in English, Chinese, German and Spanish. FDA UDI
- Model / Reference
- E-LINK Software (Version 16) EUDAMED16xx-xxx-xxxx FDA UDI
- Description
- E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities. E-LINK is available in English, Chinese, German and Spanish. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690454 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- ISD FDA UDIBXB FDA UDIION FDA UDI
- EMDN Code
- Z12069092 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Biomechanical function analysis/rehabilitation software 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
No
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 a6ec0ccc-b6a0-4b59-8749-47a10309d6d3 61 fields · synced Jul 9, 2026
- FDA UDI e96f4693-f2bb-49a7-81e9-792b8fb02b5d 33 fields · synced May 30, 2026