Identity
- Trade Name
- MAXLYTE EUDAMED
- Device Name
- Maxlyte K Electrode EUDAMED
- Model / Reference
- AVMEK-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061707102494 EUDAMED
- Basic UDI-DI
- 890617071AVMEKGA EUDAMED
- EMDN Code
- W0101070106 POTASSIUM - ELECTRODES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Cyprus EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Maxlyte by Avecon Healthcare Pvt. Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 890617071AVMEKGA | Class A | Active |
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Manufacturer
- Manufacturer
- Avecon Healthcare Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000040691
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 92516e74-ed61-4374-84fd-2eab5919c403 61 fields · synced Jun 19, 2026