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Easywell
EUDAMEDClass I (EU MDR)
Ref KS-RE01Model 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-RE01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974471533418 EUDAMED
- Basic UDI-DI
- 697447153ML-03GL EUDAMED
- Direct Marketing DI
- 06974471533418 EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Liechtenstein 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
Easywell by Shantou Easywell Electronic Technologies 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 | 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 bd737c35-1853-4a74-b1be-693f0f3f19c0 61 fields · synced Jun 18, 2026