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Easywell
EUDAMEDClass I (EU MDR)
Ref KS-Q5-3BModel KS-Q5,KS-Q5-3D,KS-Q5-3S,KS-Q5-3B,KS-Q5N,KS-Q5N-3D,KS-Q5N-3S,KS-Q5N-3B,KS-RE01,KS-RE01-3D,KS-RE01-3S,KS-RE01-3B,KS-Q3,KS-Q3D,KS-Q3S,KS-Q3B,KS-Q35,KS-Q50,KS-ID
Identity
- Trade Name
- EASYWELL EUDAMED
- Device Name
- Medical lights EUDAMED
- Model / Reference
- KS-Q5,KS-Q5-3D,KS-Q5-3S,KS-Q5-3B,KS-Q5N,KS-Q5N-3D,KS-Q5N-3S,KS-Q5N-3B,KS-RE01,KS-RE01-3D,KS-RE01-3S,KS-RE01-3B,KS-Q3,KS-Q3D,KS-Q3S,KS-Q3B,KS-Q35,KS-Q50,KS-ID EUDAMEDKS-Q5-3B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974471533272 EUDAMED
- Basic UDI-DI
- 697447153ML-03GL EUDAMED
- Direct Marketing DI
- 06974471533272 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Easywell by Shantou Easywell Electronic Technologies Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697447153ML-03GL | Class I | Active |
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Manufacturer
- Manufacturer
- Shantou Easywell Electronic Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000016725
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8e029394-e944-4091-85a4-d87310895f72 61 fields · synced Jun 18, 2026