Identity
- Trade Name
- Q-FLOW 2 CM MAX LOW EUDAMED
- Device Name
- Q-Flow 1 & 2 surgical light systems EUDAMED
- Model / Reference
- 52020312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438435203125 EUDAMED
- Basic UDI-DI
- 6438435SL0001Q2 EUDAMED
- Direct Marketing DI
- 06438435203125 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Category: Operating room light system
Q-Flow 2 Cm Max Low by Merivaara Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Manufacturer's product page: Q-Flow
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 | 6438435SL0001Q2 | Class I | Active |
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Manufacturer
- Manufacturer
- Merivaara Corporation
- EUDAMED SRN
- FI-MF-000001175
Sources (1)
- EUDAMED e29a01ca-7684-45fd-8271-da20b37bacc7 61 fields · synced Jul 30, 2026