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Easywell

EUDAMED

Class I (EU MDR)

Ref KS-Q5Model 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-IDRef KS-1088UModel KS-200、KS-2020、KS-Q10-03A、KS-Q10-03LB、KS-Q10-03C、KS-Q10-03W、KS-Q10-02A、KS-Q10-02B、KS-Q10-02LB、KS-Q10-02C、KS-Q10-02W、KS-Q10-02R、KS-1088、KS-1088U Ref KS-Q5N-3BRef KS-300Model KS-F0503,KS-F0505,KS-F0303,KS-F05,KS-F03,KS-3030,KS-300Ref KS-Q3Ref ETC-10Model FHD01,EM32-4KA,UPS01,ETC-10,ETC-5,DVR-1Ref KS-Q50Ref KS-Q5NRef KS-LA-6SModel KS-Q7-02C,KS-Q7-02A,KS-Q7-02LB,KS-Q7-02W,KS-Q7-02R,KS-Q7,KS-Q7LB,KS-Q7E,KS-Q6,KS-Q6LB,KS-Q6D,KS-Q6S,KS-Q6B,KS-LA-6D,KS-LA-6S,KS-LA-6B,Ref KS-Q5-3DRef KS-Q3BRef KS-Q7Ref KS-RE01-3SRef KS-LA-6BRef KS-Q10-02BRef KS-Q10-03CRef KS-5050UTModel KS-7050UT,KS-7070UT,KS-5050UT,KS-700UT,KS-500UT,Ref KS-Q6DRef KS-H1NModel 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-PLRef KS-Q10-03LBRef KS-200Ref KS-Q10-03WRef KS-Q10-02WRef FHD01Ref KS-RE01-3DRef KS-500Model KS-7050、KS-7070、KS-5050、KS-700、KS-500 Ref KS-Q3SRef KS-WL16Ref MST-PLRef KS-Q6SRef KS-700Ref UPS01Ref KS-Q10-03ARef KS-700UTRef KS-F03Ref KS-Q35Ref KS-LA-6PRef KS-Q6Ref KS-1082BRef KS-IP48Ref DVR-1Ref MST-4000IVRef KS-D01Ref MST-4000IIRef KS-F0503Ref KS-F0505Ref KS-7070Ref KS-Q7ERef KS-Q7-02LBRef KS-Q5-3SRef KS-7070UTRef ETC-5Ref KS-Q5N-3SRef KS-500UTRef KS-1088Ref KS-Q7-02WRef KS-Q5-3BRef KS-Q6BRef KS-LA-6DRef KS-RE01-3BRef KS-F05Ref KS-IP48BTRef KS-Q3D

by Shantou Easywell Electronic Technologies Co., Ltd.

Identity

Trade Name
EASYWELL EUDAMED
Device Name
Medical lights EUDAMED
Shadowless Operation Light 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 EUDAMED
KS-Q5 EUDAMED
KS-200、KS-2020、KS-Q10-03A、KS-Q10-03LB、KS-Q10-03C、KS-Q10-03W、KS-Q10-02A、KS-Q10-02B、KS-Q10-02LB、KS-Q10-02C、KS-Q10-02W、KS-Q10-02R、KS-1088、KS-1088U EUDAMED
KS-1088U EUDAMED
KS-Q5N-3B EUDAMED
KS-F0503,KS-F0505,KS-F0303,KS-F05,KS-F03,KS-3030,KS-300 EUDAMED
KS-300 EUDAMED
KS-Q3 EUDAMED
FHD01,EM32-4KA,UPS01,ETC-10,ETC-5,DVR-1 EUDAMED
ETC-10 EUDAMED
KS-Q50 EUDAMED
KS-Q5N EUDAMED
KS-Q7-02C,KS-Q7-02A,KS-Q7-02LB,KS-Q7-02W,KS-Q7-02R,KS-Q7,KS-Q7LB,KS-Q7E,KS-Q6,KS-Q6LB,KS-Q6D,KS-Q6S,KS-Q6B,KS-LA-6D,KS-LA-6S,KS-LA-6B, EUDAMED
KS-LA-6S EUDAMED
KS-Q5-3D EUDAMED
KS-Q3B EUDAMED
KS-Q7 EUDAMED
KS-RE01-3S EUDAMED
KS-LA-6B EUDAMED
KS-Q10-02B EUDAMED
KS-Q10-03C EUDAMED
KS-7050UT,KS-7070UT,KS-5050UT,KS-700UT,KS-500UT, EUDAMED
KS-5050UT EUDAMED
KS-Q6D EUDAMED
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 EUDAMED
KS-H1N EUDAMED
KS-Q10-03LB EUDAMED
KS-200 EUDAMED
KS-Q10-03W EUDAMED
KS-Q10-02W EUDAMED
FHD01 EUDAMED
KS-RE01-3D EUDAMED
KS-7050、KS-7070、KS-5050、KS-700、KS-500 EUDAMED
KS-500 EUDAMED
KS-Q3S EUDAMED
KS-WL16 EUDAMED
MST-PL EUDAMED
KS-Q6S EUDAMED
KS-700 EUDAMED
UPS01 EUDAMED
KS-Q10-03A EUDAMED
KS-700UT EUDAMED
KS-F03 EUDAMED
KS-Q35 EUDAMED
KS-LA-6P EUDAMED
KS-Q6 EUDAMED
KS-1082B EUDAMED
KS-IP48 EUDAMED
DVR-1 EUDAMED
MST-4000IV EUDAMED
KS-D01 EUDAMED
MST-4000II EUDAMED
KS-F0503 EUDAMED
KS-F0505 EUDAMED
KS-7070 EUDAMED
KS-Q7E EUDAMED
KS-Q7-02LB EUDAMED
KS-Q5-3S EUDAMED
KS-7070UT EUDAMED
ETC-5 EUDAMED
KS-Q5N-3S EUDAMED
KS-500UT EUDAMED
KS-1088 EUDAMED
KS-Q7-02W EUDAMED
KS-Q5-3B EUDAMED
KS-Q6B EUDAMED
KS-LA-6D EUDAMED
KS-RE01-3B EUDAMED
KS-F05 EUDAMED
KS-IP48BT EUDAMED
KS-Q3D EUDAMED

Identifiers

Primary DI / UDI-DI
06974471533197 EUDAMED
06974471532718 EUDAMED
06974471533388 EUDAMED
06974471533180 EUDAMED
06974471532442 EUDAMED
06974471533548 EUDAMED
06974471533173 EUDAMED
06974471532169 EUDAMED
06974471533944 EUDAMED
06974471533302 EUDAMED
06974471533074 EUDAMED
06974471533203 EUDAMED
06974471533647 EUDAMED
06974471532831 EUDAMED
06974471533470 EUDAMED
06974471533159 EUDAMED
06974471532626 EUDAMED
06974471532510 EUDAMED
06974471532848 EUDAMED
06974471532213 EUDAMED
06974471532916 EUDAMED
06974471533845 EUDAMED
06974471532589 EUDAMED
06974471533111 EUDAMED
06974471532480 EUDAMED
06974471532596 EUDAMED
06974471532640 EUDAMED
06974471532121 EUDAMED
06974471532541 EUDAMED
06974471532428 EUDAMED
06974471533456 EUDAMED
06974471532107 EUDAMED
06974471533401 EUDAMED
06974471533616 EUDAMED
06974471532077 EUDAMED
06974471533708 EUDAMED
06974471533937 EUDAMED
06974471532978 EUDAMED
06974471532039 EUDAMED
06974471532152 EUDAMED
06974471533227 EUDAMED
06974471532558 EUDAMED
06974471532244 EUDAMED
06974471532404 EUDAMED
06974471532756 EUDAMED
06974471533487 EUDAMED
06974471533661 EUDAMED
06974471533098 EUDAMED
06974471532923 EUDAMED
06974471533784 EUDAMED
06974471532374 EUDAMED
06974471532862 EUDAMED
06974471533692 EUDAMED
06974471533722 EUDAMED
06974471532183 EUDAMED
06974471533906 EUDAMED
06974471533869 EUDAMED
06974471533883 EUDAMED
06974471532305 EUDAMED
06974471532312 EUDAMED
06974471532015 EUDAMED
06974471532855 EUDAMED
06974471532787 EUDAMED
06974471533234 EUDAMED
06974471533449 EUDAMED
06974471532565 EUDAMED
06974471532206 EUDAMED
06974471533258 EUDAMED
06974471532886 EUDAMED
06974471532091 EUDAMED
06974471532176 EUDAMED
06974471533371 EUDAMED
06974471533630 EUDAMED
06974471532268 EUDAMED
06974471532664 EUDAMED
06974471532527 EUDAMED
06974471532817 EUDAMED
06974471532794 EUDAMED
06974471533289 EUDAMED
06974471533012 EUDAMED
06974471532053 EUDAMED
06974471533036 EUDAMED
06974471532275 EUDAMED
06974471533678 EUDAMED
06974471533128 EUDAMED
06974471533517 EUDAMED
06974471532336 EUDAMED
06974471533609 EUDAMED
06974471533463 EUDAMED
06974471533746 EUDAMED
06974471533241 EUDAMED
06974471532961 EUDAMED
06974471533654 EUDAMED
06974471533562 EUDAMED
06974471532350 EUDAMED
06974471532473 EUDAMED
06974471532343 EUDAMED
06974471533524 EUDAMED
Basic UDI-DI
697447153ML-03GL EUDAMED
697447153ML-01GG EUDAMED
697447153OL-PTLQG EUDAMED
697447153OL-ACCKY EUDAMED
697447153ML-02GJ EUDAMED
697447153OL-STCQD EUDAMED
697447153ML-04GN EUDAMED
697447153OL-ECOMC EUDAMED
Direct Marketing DI
06974471533197 EUDAMED
06974471532718 EUDAMED
06974471533388 EUDAMED
06974471533180 EUDAMED
06974471532442 EUDAMED
06974471533548 EUDAMED
06974471533173 EUDAMED
06974471532169 EUDAMED
06974471533944 EUDAMED
06974471533302 EUDAMED
06974471533074 EUDAMED
06974471533203 EUDAMED
06974471533647 EUDAMED
06974471532831 EUDAMED
06974471533470 EUDAMED
06974471533159 EUDAMED
06974471532626 EUDAMED
06974471532510 EUDAMED
06974471532848 EUDAMED
06974471532213 EUDAMED
06974471532916 EUDAMED
06974471533845 EUDAMED
06974471532589 EUDAMED
06974471533111 EUDAMED
06974471532480 EUDAMED
06974471532596 EUDAMED
06974471532640 EUDAMED
06974471532121 EUDAMED
06974471532541 EUDAMED
06974471532428 EUDAMED
06974471533456 EUDAMED
06974471532107 EUDAMED
06974471533401 EUDAMED
06974471533616 EUDAMED
06974471532077 EUDAMED
06974471533708 EUDAMED
06974471533937 EUDAMED
06974471532978 EUDAMED
06974471532039 EUDAMED
06974471532152 EUDAMED
06974471533227 EUDAMED
06974471532558 EUDAMED
06974471532244 EUDAMED
06974471532404 EUDAMED
06974471532756 EUDAMED
06974471533487 EUDAMED
06974471533661 EUDAMED
06974471533098 EUDAMED
06974471532923 EUDAMED
06974471533784 EUDAMED
06974471532374 EUDAMED
06974471532862 EUDAMED
06974471533692 EUDAMED
06974471533722 EUDAMED
06974471532183 EUDAMED
06974471533906 EUDAMED
06974471533869 EUDAMED
06974471533883 EUDAMED
06974471532305 EUDAMED
06974471532312 EUDAMED
06974471532015 EUDAMED
06974471532855 EUDAMED
06974471532787 EUDAMED
06974471533234 EUDAMED
06974471533449 EUDAMED
06974471532565 EUDAMED
06974471532206 EUDAMED
06974471533258 EUDAMED
06974471532886 EUDAMED
06974471532091 EUDAMED
06974471532176 EUDAMED
06974471533371 EUDAMED
06974471533630 EUDAMED
06974471532268 EUDAMED
06974471532664 EUDAMED
06974471532527 EUDAMED
06974471532817 EUDAMED
06974471532794 EUDAMED
06974471533289 EUDAMED
06974471533012 EUDAMED
06974471532053 EUDAMED
06974471533036 EUDAMED
06974471532275 EUDAMED
06974471533678 EUDAMED
06974471533128 EUDAMED
06974471533517 EUDAMED
06974471532336 EUDAMED
06974471533609 EUDAMED
06974471533463 EUDAMED
06974471533746 EUDAMED
06974471533241 EUDAMED
06974471532961 EUDAMED
06974471533654 EUDAMED
06974471533562 EUDAMED
06974471532350 EUDAMED
06974471532473 EUDAMED
06974471532343 EUDAMED
06974471533524 EUDAMED
EMDN Code
Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
Z12010780 SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED
Belgium EUDAMED
Czechia EUDAMED
Norway EUDAMED
Denmark EUDAMED
Austria EUDAMED
Estonia EUDAMED
Cyprus EUDAMED
Germany EUDAMED
Croatia EUDAMED
Hungary EUDAMED
Latvia EUDAMED
Iceland EUDAMED
Finland EUDAMED
Ireland EUDAMED
Poland EUDAMED
Bulgaria EUDAMED
Portugal EUDAMED
Slovakia EUDAMED
Greece EUDAMED
Romania EUDAMED
Lithuania 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

Similar devices

Also classified as Operating room light system.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shantou Easywell Electronic Technologies Co., Ltd.
EUDAMED SRN
CN-MF-000016725
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (98)

  • EUDAMED 40574808-9064-4018-af87-4fe95b93f5ce 61 fields · synced Oct 1, 2026
  • EUDAMED 6c03fa06-d009-409d-bf08-036c97857765 61 fields · synced May 11, 2026
  • EUDAMED 073f62d0-4d5c-4f49-a6b7-0429e1c337a4 61 fields · synced May 11, 2026
  • EUDAMED 1a348fb1-1252-4cdc-9f56-aeb53cf5b627 61 fields · synced May 11, 2026
  • EUDAMED 25dfa53f-beb1-40be-a07a-d26a7a4281b1 61 fields · synced May 16, 2026
  • EUDAMED 8950f98e-8034-42c7-9cf1-31e4360437a9 61 fields · synced May 16, 2026
  • EUDAMED f100dacd-486c-4045-8f30-e716867fc68a 61 fields · synced May 16, 2026
  • EUDAMED 8348a20b-2399-48bc-bbe1-eac9058dd2a7 61 fields · synced May 16, 2026
  • EUDAMED e8ba127a-b070-4b0a-a848-6aba38bac027 61 fields · synced May 16, 2026
  • EUDAMED 01484d93-ebec-4e8f-a720-864387eb9618 61 fields · synced May 16, 2026
  • EUDAMED 37298f54-5edd-4d20-b63f-cdc64d0d9e92 61 fields · synced May 16, 2026
  • EUDAMED 9492f887-2dc4-4f87-8c36-1a8de368689e 61 fields · synced May 16, 2026
  • EUDAMED 48e39988-5b6f-4a19-b01d-300c912cc27c 61 fields · synced May 16, 2026
  • EUDAMED ad632763-7f34-41fb-ada6-0ae4403ae536 61 fields · synced May 16, 2026
  • EUDAMED 78ae841d-9310-450a-a0d3-0e52637a9d03 61 fields · synced May 16, 2026
  • EUDAMED a38c78c9-20d4-4ad2-adc1-687752e766a0 61 fields · synced May 16, 2026
  • EUDAMED cd313ae9-c6e6-44fd-88bf-49efaf9b8117 61 fields · synced May 17, 2026
  • EUDAMED af060bdf-8580-451c-858e-aef4faff78cf 61 fields · synced May 17, 2026
  • EUDAMED 692ea204-cc21-4f6a-8bbf-b0a3e2616d1a 61 fields · synced May 17, 2026
  • EUDAMED ab3950f9-eeec-44ac-b8e3-432e88943fa2 61 fields · synced May 17, 2026
  • EUDAMED 2428c365-e887-46fb-8b5f-9dfad13590ea 61 fields · synced May 17, 2026
  • EUDAMED e3054b8b-c92a-4c34-9c59-a9be7b30b2a4 61 fields · synced May 17, 2026
  • EUDAMED 543dd6c5-7c4a-4365-81bb-0c193f3743a9 61 fields · synced May 17, 2026
  • EUDAMED 4c61dedc-934d-47dd-bcb3-337766a8f407 61 fields · synced May 17, 2026
  • EUDAMED 222c5e2e-c3ea-4798-afc3-35d647eea9e5 61 fields · synced May 17, 2026
  • EUDAMED 760bba0e-5c4a-4a11-9c85-53f6959c4a04 61 fields · synced May 17, 2026
  • EUDAMED 9a139e84-0938-43a4-9d33-acde0de50620 61 fields · synced May 17, 2026
  • EUDAMED 8d6b523e-72a9-466d-82d8-1c3aa5e31f05 61 fields · synced May 17, 2026
  • EUDAMED 089ee542-2290-46c3-be2b-ba5c950f52c8 61 fields · synced May 17, 2026
  • EUDAMED 5c25454f-fc8d-449f-845d-014b2807faaa 61 fields · synced May 17, 2026
  • EUDAMED f6c400f8-81eb-4fb2-ba5b-68947c44f26c 61 fields · synced May 17, 2026
  • EUDAMED 5565b2c2-5b57-437f-be44-432c7c477130 61 fields · synced May 17, 2026
  • EUDAMED 2df66cb1-6209-41ef-b03a-e46d2d0f7d72 61 fields · synced May 17, 2026
  • EUDAMED bf035322-7f3b-48ed-9c02-d5c119eebd3c 61 fields · synced May 17, 2026
  • EUDAMED a0a4c86f-2d1f-4a54-a6f4-570ce273d2a1 61 fields · synced May 17, 2026
  • EUDAMED 7e467d02-36a9-40ec-af73-6df0c9b822b0 61 fields · synced May 17, 2026
  • EUDAMED 2b5c957b-327e-4013-9643-cda678c6be2b 61 fields · synced May 17, 2026
  • EUDAMED 78cc569a-8917-4bdd-9200-a59a44ed62b8 61 fields · synced May 17, 2026
  • EUDAMED ceee0c50-2cc0-4df7-9662-b8291b5ba320 61 fields · synced May 17, 2026
  • EUDAMED bb6d6d4e-0425-4b15-91d9-2bdac9c0dae1 61 fields · synced May 17, 2026
  • EUDAMED 0b5ea38f-1ef2-45eb-bc47-7b3fe8416e6d 61 fields · synced May 17, 2026
  • EUDAMED add10bb7-2abf-4cb8-9d6d-da71c171e421 61 fields · synced May 17, 2026
  • EUDAMED 2d26be87-0478-4d9d-bdfb-d18b2e6cc4e7 61 fields · synced May 17, 2026
  • EUDAMED 2aae2328-8fe9-436d-8e5b-79a0d17888ce 61 fields · synced May 17, 2026
  • EUDAMED 7a8aa369-6d52-4695-9b86-81e83d8462c0 61 fields · synced May 17, 2026
  • EUDAMED 215bafcf-fab5-46da-99a6-ba44554dcba5 61 fields · synced May 17, 2026
  • EUDAMED 71fbeb9b-d077-4219-bbc6-9219d176d9c3 61 fields · synced May 17, 2026
  • EUDAMED 70fe10f1-b44e-41c3-80b9-445e4d265e57 61 fields · synced May 17, 2026
  • EUDAMED c21201a0-0a58-4eb7-b480-8595b27522d8 61 fields · synced May 17, 2026
  • EUDAMED 1dd9b62b-0bf8-4419-b2d1-2e3758db1db3 61 fields · synced May 17, 2026
  • EUDAMED e6efa85e-c30b-4b47-b7f9-c39862b05595 61 fields · synced May 17, 2026
  • EUDAMED f11259e6-892b-4079-881a-1c78486d0ad2 61 fields · synced May 17, 2026
  • EUDAMED 503a8aca-1551-4eea-99b5-1ceeea911bce 61 fields · synced May 18, 2026
  • EUDAMED 9ebfd8d0-f0ad-4043-a67e-17fdae7e809b 61 fields · synced May 18, 2026
  • EUDAMED c624a010-8eaf-4aaf-8a11-1dc12465bce3 61 fields · synced May 18, 2026
  • EUDAMED 989fa56e-6662-4ed7-86e6-3e224bf5da71 61 fields · synced May 18, 2026
  • EUDAMED cd148258-59c0-4693-b51c-a17fb9e41af4 61 fields · synced May 18, 2026
  • EUDAMED d35ba49e-4a8c-420f-9c12-64986c6d7e0d 61 fields · synced May 18, 2026
  • EUDAMED 9649a8b6-7f64-4545-9430-ea399f2b70dc 61 fields · synced May 18, 2026
  • EUDAMED 3ab4beba-d10d-49c0-bd1a-a81f47728c2e 61 fields · synced May 18, 2026
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