Identity
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMED
- Model / Reference
- M550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060481692748 EUDAMED
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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 Evaluation and Exercise Systems 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 (1)
- EUDAMED b4b48b63-1a55-4638-a2e6-6cf5523579ba 61 fields · synced Jun 19, 2026