Identity
- Trade Name
- E-LINK EUDAMEDE-LINK Upper Limb Exerciser FDA UDI
- Generic Name
- Electronic torsional hand exerciser FDA UDI
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMED"The E-LINK Upper Limb Exerciser is designed for active and active resistive upper extremity exercise of the wrist, forearm, elbow, and shoulder. The versatility of the parameters allows rehabilitation for a wide range of orthopedic and neurological patients. The Upper Limb Exerciser is available with either a wireless or wired interface to the computer." FDA UDI
- Model / Reference
- E4000 Upper Limb Exerciser EUDAMEDE4000 FDA UDI
- Description
- "The E-LINK Upper Limb Exerciser is designed for active and active resistive upper extremity exercise of the wrist, forearm, elbow, and shoulder. The versatility of the parameters allows rehabilitation for a wide range of orthopedic and neurological patients. The Upper Limb Exerciser is available with either a wireless or wired interface to the computer." FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690010 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- ION FDA UDIISD FDA UDI
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
- GMDN Term
- Electronic torsional hand exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 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
Yes
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 f41cb00f-c82c-4579-b31e-144e08ec3749 61 fields · synced May 30, 2026
- FDA UDI b8700fd1-f0d8-45a9-bc16-7905602dfe7d 33 fields · synced May 30, 2026