Identity
- Device Name
- INFINITT DoseM EUDAMED
- Model / Reference
- 1307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809278790154 EUDAMED
- Basic UDI-DI
- 880927879DoseM85 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
INFINITT DoseM by Infinitt Healthcare Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880927879DoseM85 | Class I | 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 (1)
- EUDAMED 431e1530-6aeb-4763-b74e-eaff4993b571 61 fields · synced Jun 19, 2026