Identity
- Trade Name
- Auto Hematology Analyzer EUDAMED
- Device Name
- Auto Hematology Analyzer EUDAMED
- Model / Reference
- HEMA-D6031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975488440010 EUDAMED
- Basic UDI-DI
- 697548844HEMA22S2 EUDAMED
- Direct Marketing DI
- 06975488440010 EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Auto 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 | 697548844HEMA22S2 | Class A | Active |
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Manufacturer
- Manufacturer
- Infitek Co., Ltd.
- EUDAMED SRN
- CN-MF-000040107
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 87e8d59f-2265-400e-84e9-c4109f9dd40b 61 fields · synced Jun 19, 2026