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E-Link
EUDAMEDClass I (EU MDR)
Ref NC5 AngleX Sensor Small (Wireless)Ref E-LINK SW, Lower Extremity EvaluationRef E-LINK SW, Impairment EvaluationRef P5R
Identity
- Trade Name
- E-LINK EUDAMEDP5R (pack of 5 rolls) EUDAMED
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMEDE-LINK Accessories EUDAMED
- Model / Reference
- NC5 AngleX Sensor Small (Wireless) EUDAMEDE-LINK SW, Lower Extremity Evaluation EUDAMEDE-LINK SW, Impairment Evaluation EUDAMEDP5R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060481690164 EUDAMED05060481692519 EUDAMED05060481692502 EUDAMED05060481690355 EUDAMED
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED506048169AccessoriesRBSY EUDAMED
- EMDN Code
- Z12062402 POSITIONAL BIOFEEDBACK SYSTEMS EUDAMEDZ12069092 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMEDH900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDMalta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
E-Link by Biometrics Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506048169E-LINKY3 | Class I | Active |
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Manufacturer
- Manufacturer
- Biometrics Ltd
- EUDAMED SRN
- GB-MF-000002774
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (7)
- EUDAMED 896d7b89-bad6-47e4-bd1c-4ca83fff0fe5 61 fields · synced Sep 17, 2026
- EUDAMED b393cd05-58c6-4c0e-90a3-61cfbfaac141 61 fields · synced May 18, 2026
- EUDAMED d38f81ce-3af2-4d90-ab38-d6dd90fca86b 61 fields · synced May 18, 2026
- EUDAMED f5ce2985-2ebe-4afe-9dac-48a75124d36f 61 fields · synced May 18, 2026
- EUDAMED d38f81ce-3af2-4d90-ab38-d6dd90fca86b-1 61 fields · synced Jul 18, 2026
- EUDAMED b393cd05-58c6-4c0e-90a3-61cfbfaac141-1 61 fields · synced Jul 20, 2026
- EUDAMED 86de4768-84b4-4578-ab80-7404bbfa0e66 61 fields · synced Sep 17, 2026