Identity
- Trade Name
- DO2.1 EUDAMED
- Device Name
- Dental suction unit EUDAMED
- Model / Reference
- 440021401-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586014625313 EUDAMED
- Basic UDI-DI
- 858601462000006L7 EUDAMED
- Direct Marketing DI
- 08586014625313 EUDAMED
- EMDN Code
- Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Do2.1 by EKOM spol. s r.o. — 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 | 858601462000006L7 | Class I | Active |
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Manufacturer
- Manufacturer
- EKOM spol. s r.o.
- EUDAMED SRN
- SK-MF-000002069
Sources (1)
- EUDAMED 04fcf806-a24d-48e4-9c46-ba836056ffab 61 fields · synced Jul 20, 2026