Identity
- Trade Name
- MAXCOUNT BH560 EUDAMED
- Device Name
- Auto Hematology Analyzer EUDAMED
- Model / Reference
- AVBH 560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061707101268 EUDAMED
- Basic UDI-DI
- 890617071AVMAXCOUNTK2 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) 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
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Maxcount Bh560 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 | 890617071AVMAXCOUNTK2 | 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 c95ef4f9-78b3-4155-a38f-71455e236518 61 fields · synced Jun 18, 2026