Identity
- Trade Name
- Hematology Analyzer EUDAMED
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- HEMA Series EUDAMEDIN0123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978507780135 EUDAMED
- Basic UDI-DI
- 697850778HEM10QH EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Hematology Analyzer by Infitek Co., 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 | 697850778HEM10QH | Class A | Active |
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Manufacturer
- Manufacturer
- Infitek Co., Ltd.
- EUDAMED SRN
- CN-MF-000048840
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED ca99541a-64db-41b6-ac93-8fa128fb1ccb 61 fields · synced Jul 11, 2026