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Easywell
EUDAMEDClass I (EU MDR)
Ref KS-7050UTModel KS-7050UT,KS-7070UT,KS-5050UT,KS-700UT,KS-500UT,
Identity
- Trade Name
- EASYWELL EUDAMED
- Device Name
- Shadowless Operation Light EUDAMED
- Model / Reference
- KS-7050UT,KS-7070UT,KS-5050UT,KS-700UT,KS-500UT, EUDAMEDKS-7050UT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974471532190 EUDAMED
- Basic UDI-DI
- 697447153OL-STCQD EUDAMED
- Direct Marketing DI
- 06974471532190 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 | 697447153OL-STCQD | 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 21ccb331-8ec1-4f44-a126-7ea771f3cf53 61 fields · synced Jun 19, 2026