Easywell
by Shantou Easywell Electronic Technologies Co., Ltd. 82 variants
Part of a family of 18 devices: see the family page
Ref KS-Q3 BlackModel 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
Easywell (KS-Q3 Black) is a Class I device made by Shantou Easywell Electronic Technologies Co., Ltd., registered in EUDAMED on 26 Mar 2026 (Basic UDI-DI 697447153ML-03GL), active as of 23 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697447153ML-03GL 06974471530011 | Date26 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 697447153ML-03GL
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Medical lights
- 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, KS-Q3 Black
- Primary DI / UDI-DI
- 06974471530011
- Basic UDI-DI
- 697447153ML-03GL
- Direct marketing DI
- 06974471530011
- EMDN code
- Z12010702 Mobile scialytic lamps
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Croatia
Manufacturer details
- EUDAMED SRN
- CN-MF-000016725
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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