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AutoMax
EUDAMEDClass A (EU MDR)
Ref AutoMax 200Ref SPDET-160Ref AutoMax 400Ref AutoMax 800
Identity
- Trade Name
- AutoMax EUDAMED
- Device Name
- FULLY AUTO BIOCHEMISTRY ANALYZER EUDAMEDAutoMax Alkaline wash solution EUDAMED
- Model / Reference
- AutoMax 200 EUDAMEDSPDET-160 EUDAMEDAutoMax 400 EUDAMEDAutoMax 800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061707100582 EUDAMED89061707101572 EUDAMED89061707100650 EUDAMED89061707100728 EUDAMED
- Basic UDI-DI
- 890617071AVAUTOMAXUN EUDAMED890617071SPDETLB EUDAMED
- EMDN Code
- W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400) EUDAMEDW02050109 CELL WASHERS EUDAMEDW0201010106 CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800) EUDAMEDW0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200) 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
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
AutoMax 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 | 890617071AVAUTOMAXUN | 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 (4)
- EUDAMED 26468a54-6e3d-4705-85dc-3fe9279623ea 61 fields · synced Aug 2, 2026
- EUDAMED e6b7c172-4799-4efd-9db2-c5406a4d3bcd 61 fields · synced May 18, 2026
- EUDAMED 8143ad08-94e3-4b44-bb47-a77965aaeb38 61 fields · synced May 18, 2026
- EUDAMED d4fe838d-1211-441d-ba45-df2749731a13 61 fields · synced May 18, 2026