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Easywell
EUDAMEDClass I (EU MDR)
Ref KS-LA-6DModel 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-Q35Ref KS-H1NRef KS-MC01Ref KS-Q10Ref DL-06Ref KS-Q10-03 Ref E22ARef KS-W02Ref KS-3030Model KS-F0503,KS-F0505,KS-F0303,KS-F05,KS-F03,KS-3030,KS-300Ref KS-ELS03Ref E22BRef KS-F05Ref MST-4000IRef KS-Q3 Ref MST-4000IIIRef KS-Q6Ref KS-ELS100ARef KS-700Model KS-7050、KS-7070、KS-5050、KS-700、KS-500 Ref KS-M350Ref KS-CM2012-SRef KS-7050+CRef KS-500UTModel KS-7050UT,KS-7070UT,KS-5050UT,KS-700UT,KS-500UT,Ref KS-7050Ref IDRef E40BRef E33Ref E20Ref KS-500Ref KS-Q7Ref KS-F0503Ref KS-IP48Ref KS-Q5NRef KS-IP100Ref KS-5050Ref KS-1088Ref KS-F03Ref KS-200
Identity
- Trade Name
- EASYWELL EUDAMEDMedical lights EUDAMED
- Device Name
- Medical lights EUDAMEDShadowless Operation Light EUDAMED
- Model / Reference
- 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, EUDAMEDKS-LA-6D EUDAMEDKS-Q35 EUDAMEDKS-H1N EUDAMEDKS-MC01 EUDAMEDKS-Q10 EUDAMEDDL-06 EUDAMEDKS-Q10-03 EUDAMEDE22A EUDAMEDKS-W02 EUDAMEDKS-F0503,KS-F0505,KS-F0303,KS-F05,KS-F03,KS-3030,KS-300 EUDAMEDKS-3030 EUDAMEDKS-ELS03 EUDAMEDE22B EUDAMEDKS-F05 EUDAMEDMST-4000I EUDAMEDKS-Q3 EUDAMEDMST-4000III EUDAMEDKS-Q6 EUDAMEDKS-ELS100A EUDAMEDKS-7050、KS-7070、KS-5050、KS-700、KS-500 EUDAMEDKS-700 EUDAMEDKS-M350 EUDAMEDKS-CM2012-S EUDAMEDKS-7050+C EUDAMEDKS-7050UT,KS-7070UT,KS-5050UT,KS-700UT,KS-500UT, EUDAMEDKS-500UT EUDAMEDKS-7050 EUDAMEDID EUDAMEDE40B EUDAMEDE33 EUDAMEDE20 EUDAMEDKS-500 EUDAMEDKS-Q7 EUDAMEDKS-F0503 EUDAMEDKS-IP48 EUDAMEDKS-Q5N EUDAMEDKS-IP100 EUDAMEDKS-5050 EUDAMEDKS-1088 EUDAMEDKS-F03 EUDAMEDKS-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974471533067 EUDAMED16974471530001 EUDAMED16974471530124 EUDAMED16974471530117 EUDAMED16974471530063 EUDAMED16974471530681 EUDAMED16974471530339 EUDAMED16974471530742 EUDAMED16974471530070 EUDAMED06974471532411 EUDAMED16974471530155 EUDAMED16974471530759 EUDAMED16974471530315 EUDAMED16974471530346 EUDAMED16974471530018 EUDAMED16974471530360 EUDAMED16974471530049 EUDAMED16974471530162 EUDAMED06974471532046 EUDAMED16974471530254 EUDAMED16974471530698 EUDAMED16974471530285 EUDAMED06974471532299 EUDAMED16974471530193 EUDAMED16974471530209 EUDAMED16974471530278 EUDAMED16974471530797 EUDAMED16974471530766 EUDAMED16974471530735 EUDAMED16974471530186 EUDAMED16974471530087 EUDAMED16974471530056 EUDAMED16974471530292 EUDAMED16974471530643 EUDAMED16974471530032 EUDAMED16974471530650 EUDAMED16974471530223 EUDAMED16974471530230 EUDAMED16974471530322 EUDAMED16974471530674 EUDAMED
- Basic UDI-DI
- 697447153ML-02GJ EUDAMED697447153000L4 EUDAMED697447153012LB EUDAMED697447153011L9 EUDAMED697447153006LG EUDAMED697447153068M6 EUDAMED697447153033LK EUDAMED697447153074LZ EUDAMED697447153007LJ EUDAMED697447153OL-PTLQG EUDAMED697447153015LH EUDAMED697447153075M3 EUDAMED697447153031LF EUDAMED697447153034LM EUDAMED697447153001L6 EUDAMED697447153036LR EUDAMED697447153004LC EUDAMED697447153016LK EUDAMED697447153OL-ECOMC EUDAMED697447153025LL EUDAMED697447153069M8 EUDAMED697447153028LS EUDAMED697447153OL-STCQD EUDAMED697447153019LR EUDAMED697447153020LA EUDAMED697447153027LQ EUDAMED697447153079MB EUDAMED697447153076M5 EUDAMED697447153073LX EUDAMED697447153018LP EUDAMED697447153008LL EUDAMED697447153005LE EUDAMED697447153029LU EUDAMED697447153064LW EUDAMED697447153003LA EUDAMED697447153065LY EUDAMED697447153022LE EUDAMED697447153023LG EUDAMED697447153032LH EUDAMED697447153067M4 EUDAMED
- Direct Marketing DI
- 06974471533067 EUDAMED16974471530001 EUDAMED16974471530124 EUDAMED16974471530117 EUDAMED16974471530063 EUDAMED16974471530681 EUDAMED16974471530339 EUDAMED16974471530742 EUDAMED16974471530070 EUDAMED06974471532411 EUDAMED16974471530155 EUDAMED16974471530759 EUDAMED16974471530315 EUDAMED16974471530346 EUDAMED16974471530018 EUDAMED16974471530360 EUDAMED16974471530049 EUDAMED16974471530162 EUDAMED06974471532046 EUDAMED16974471530254 EUDAMED16974471530698 EUDAMED16974471530285 EUDAMED06974471532299 EUDAMED16974471530193 EUDAMED16974471530209 EUDAMED16974471530278 EUDAMED16974471530797 EUDAMED16974471530766 EUDAMED16974471530735 EUDAMED16974471530186 EUDAMED16974471530087 EUDAMED16974471530056 EUDAMED16974471530292 EUDAMED16974471530643 EUDAMED16974471530032 EUDAMED16974471530650 EUDAMED16974471530223 EUDAMED16974471530230 EUDAMED16974471530322 EUDAMED16974471530674 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMEDZ12010701,Z12010702 EUDAMEDZ12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Latvia EUDAMEDHungary EUDAMEDBulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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 | 697447153ML-02GJ | 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 (40)
- EUDAMED 1b6e80f8-d0ac-4f00-ba63-1262c5ea6f50 61 fields · synced Sep 18, 2026
- EUDAMED 3b5764ee-61a0-4617-a6c4-44e9073308df 61 fields · synced May 16, 2026
- EUDAMED c52cd0b8-9a84-4053-a899-8cf1a6b602ec 61 fields · synced May 16, 2026
- EUDAMED 0a405c66-3b30-4256-9ec0-540557209e8f 61 fields · synced May 16, 2026
- EUDAMED ffa02514-1500-4973-9f93-7a67307d6ce4 61 fields · synced May 16, 2026
- EUDAMED c2bdba53-fbff-4d4a-8892-2f4167e888b7 61 fields · synced May 16, 2026
- EUDAMED ee9c97ac-ea96-4cc3-9b21-d98a7ec01c5b 61 fields · synced May 16, 2026
- EUDAMED 8af4a91a-317d-4dcf-86f5-ebc681bc1aee 61 fields · synced May 17, 2026
- EUDAMED 844e9400-93b3-4954-8313-64e90a4a422e 61 fields · synced May 17, 2026
- EUDAMED 59e6215c-4e43-4d98-a086-08489868a037 61 fields · synced May 17, 2026
- EUDAMED d2cba7e7-4305-4834-90f8-3cdd21698152 61 fields · synced May 17, 2026
- EUDAMED 30fc4803-3b39-43e9-ab23-604640ea6d11 61 fields · synced May 17, 2026
- EUDAMED f391b8ad-6abe-419c-9a14-c75d20d18b66 61 fields · synced May 17, 2026
- EUDAMED 9bebcde6-7f9b-4b51-b6e3-b64d4ac08f1c 61 fields · synced May 17, 2026
- EUDAMED 04905b73-5043-46df-997f-f2b6686d3490 61 fields · synced May 17, 2026
- EUDAMED 321dc269-9134-4d55-bf3d-725506da34d0 61 fields · synced May 17, 2026
- EUDAMED aa6317da-b4ae-4876-a272-d79e575ded6b 61 fields · synced May 17, 2026
- EUDAMED 869c2087-c9e2-4b1b-9afa-32301ecf6ce2 61 fields · synced May 17, 2026
- EUDAMED a2c0b7cb-57be-44cf-a7e5-2d649016408c 61 fields · synced May 17, 2026
- EUDAMED 9a93dfda-d2b5-4417-9793-4a218323f213 61 fields · synced May 17, 2026
- EUDAMED 29ae2fb1-6b6d-46f0-b578-17fd14c02322 61 fields · synced May 17, 2026
- EUDAMED 96cbbd8e-c600-45f9-8a33-4c1cb2b94031 61 fields · synced May 18, 2026
- EUDAMED a4b2cdf0-83b9-4f54-a39a-44fc0a901dd8 61 fields · synced May 18, 2026
- EUDAMED b5ce507d-3a21-4331-8d2e-30c3d231f31c 61 fields · synced May 18, 2026
- EUDAMED e69f54bc-340c-4311-bc48-a6810a0d2c59 61 fields · synced May 18, 2026
- EUDAMED 25736c71-f470-45be-8a14-492f96539f60 61 fields · synced May 18, 2026
- EUDAMED 83afe44a-0166-4416-ae9a-3cfc34aae996 61 fields · synced May 18, 2026
- EUDAMED bebff09c-d61c-41fa-a9e4-7f216f5b4112 61 fields · synced May 18, 2026
- EUDAMED e7013a71-4566-4cc9-b847-336dd6225def 61 fields · synced May 18, 2026
- EUDAMED b6e89920-757f-48b5-808f-a927c8647136 61 fields · synced May 18, 2026
- EUDAMED 492a2ac6-f728-42db-86ae-cbb0235600a0 61 fields · synced May 18, 2026
- EUDAMED 67035d86-74de-4b7d-96c9-8cc0d7840708 61 fields · synced May 18, 2026
- EUDAMED 1425d72a-50af-4101-8fdb-71e7119264de 61 fields · synced May 18, 2026
- EUDAMED 0946f8d9-40bf-45fc-94a1-306905c567b2 61 fields · synced May 18, 2026
- EUDAMED d83b1a60-7db1-42e0-9de9-b9308054866d 61 fields · synced May 18, 2026
- EUDAMED 439da875-c7b2-427d-a631-631a1953ae6d 61 fields · synced May 18, 2026
- EUDAMED 28945d3b-605b-4ee9-aee1-e66f958343d2 61 fields · synced May 19, 2026
- EUDAMED bfb8afab-fe70-46b0-8799-8813f8572aac 61 fields · synced May 19, 2026
- EUDAMED c077ef17-13d8-431b-a830-1c3bf9ffc932 61 fields · synced May 19, 2026
- EUDAMED dfd4f2ac-a724-478b-90ac-56c280a36743 61 fields · synced May 19, 2026