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Maxlyte
EUDAMEDClass A (EU MDR)
Ref AVMELI-1Ref AVMECL-1Ref AVMERS-50Ref AVMEQC-12Ref AVMERP-800Ref AVMENA-1Ref AVMEPH-1
Identity
- Trade Name
- MAXLYTE EUDAMED
- Device Name
- Maxlyte Li Electrode EUDAMEDMaxlyte Cl Electrode EUDAMEDMaxlyte Reference solution EUDAMEDMaxlyte 3 Level Quality Control EUDAMEDMaxlyte Reagent pack EUDAMEDMaxlyte Na Electrode EUDAMEDMaxlyte pH Electrode EUDAMED
- Model / Reference
- AVMELI-1 EUDAMEDAVMECL-1 EUDAMEDAVMERS-50 EUDAMEDAVMEQC-12 EUDAMEDAVMERP-800 EUDAMEDAVMENA-1 EUDAMEDAVMEPH-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061707102630 EUDAMED89061707102562 EUDAMED89061707103002 EUDAMED89061707102258 EUDAMED89061707102944 EUDAMED89061707102326 EUDAMED89061707102708 EUDAMED
- Basic UDI-DI
- 890617071AVMELIK5 EUDAMED890617071AVMECLJG EUDAMED890617071AVMERSLB EUDAMED890617071AVMEQCK8 EUDAMED890617071AVMERPL5 EUDAMED890617071AVMENAJT EUDAMED890617071AVMEPHKF EUDAMED
- EMDN Code
- W0101070104 LITHIUM - ELECTRODES EUDAMEDW0101070103 CHLORIDE - ELECTRODES EUDAMEDW0101070399 REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER EUDAMEDW0101050204 ELECTROLYTE CONTROLS EUDAMEDW0101070304 COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES) EUDAMEDW0101070107 SODIUM - ELECTRODES EUDAMEDW0101060602 PH - ELECTRODES (BG) 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 | 890617071AVMELIK5 | 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 (7)
- EUDAMED 5890e6b9-9b50-4628-b11c-143f89bbea77 61 fields · synced Sep 18, 2026
- EUDAMED 076839c2-6f90-49f1-9007-f5095590828b 61 fields · synced May 17, 2026
- EUDAMED 3fc96c8b-6d6e-41a7-818e-0e3076581ef7 61 fields · synced May 17, 2026
- EUDAMED 8d1cc982-3890-417f-9ba9-2d2a903f3016 61 fields · synced May 17, 2026
- EUDAMED 29676f0f-6bef-475c-8cc0-88a09aa5d480 61 fields · synced May 18, 2026
- EUDAMED 66af1484-2c21-4e27-b5e1-a774706f3309 61 fields · synced May 18, 2026
- EUDAMED 56aa7670-7e2a-43dd-9d87-1ca70c9e6fbc 61 fields · synced May 19, 2026