Identity
- Device Name
- INFINITT DPS EUDAMED
- Model / Reference
- 129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809278790291 EUDAMED
- Basic UDI-DI
- 880927879INFINITTDPS9K EUDAMED
- EMDN Code
- W02029092 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Infinitt Dps by Infinitt Healthcare Co., Ltd. — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243449 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 880927879INFINITTDPS9K | Class A | Active |
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Manufacturer
- Manufacturer
- INFINITT Healthcare Co., Ltd.
- EUDAMED SRN
- KR-MF-000010998
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 96b5b0ef-46d6-4523-b5f5-27780491930b 85 fields · synced Jun 18, 2026
- FDA 510(k) K243449 1 fields · synced May 18, 2026