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Easywell

by Shantou Easywell Electronic Technologies Co., Ltd. 82 variants

Part of a family of 30 devices: see the family page

Ref KS-FHD02Model KS-1081D,KS-1082B,KS-WL16,KS-CM2012S,KS-IP48,KS-IP48BT,KS-LA-6P,KS-H05,KS-W01,KS-W02,KS-R01,KS-MC01,KS-H1N,KS-H2N,KS-D01,MST-4000I,MST-4000II,MST-4000III,MST-4000IV,MST-PH,MST-PX,MST-PL

Easywell (KS-FHD02) is a Class I device made by Shantou Easywell Electronic Technologies Co., Ltd., registered in EUDAMED on 26 Mar 2026 (Basic UDI-DI 697447153ML-04GN), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697447153ML-04GN Basic UDI-DI 06974471534118UDI-DIDate26 Mar 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Medical lights
Model / reference
KS-1081D, KS-1082B, KS-WL16, KS-CM2012S, KS-IP48, KS-IP48BT, KS-LA-6P, KS-H05, KS-W01, KS-W02, KS-R01, KS-MC01, KS-H1N, KS-H2N, KS-D01, MST-4000I, MST-4000II, MST-4000III, MST-4000IV, MST-PH, MST-PX, MST-PL, KS-FHD02
Primary DI / UDI-DI
06974471534118
Basic UDI-DI
697447153ML-04GN
Direct marketing DI
06974471534118
EMDN code
Z12010799 Scialytic lamp lighting systems - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000016725
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Similar devices in this category

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Properties

Other properties (14, all answered No)