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Easyvistar
EUDAMEDClass I (EU MDR)
Ref EM32-4KARef N/AModel E33Ref E10URef KS-ELAS100AModel KS-ELS100ARef KS-ELS200ARef E40ARef E42BRef E42ARef E22BRef E20BRef E43
Identity
- Trade Name
- EASYVISTAR EUDAMED
- Device Name
- Medical Endoscopic Camera Systems And Cold Light Source EUDAMED
- Model / Reference
- EM32-4KA EUDAMEDE33 EUDAMEDN/A EUDAMEDE10U EUDAMEDKS-ELS100A EUDAMEDKS-ELAS100A EUDAMEDKS-ELS200A EUDAMEDE40A EUDAMEDE42B EUDAMEDE42A EUDAMEDE22B EUDAMEDE20B EUDAMEDE43 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974471531698 EUDAMED06974471531513 EUDAMED06974471531605 EUDAMED06974471531636 EUDAMED06974471531643 EUDAMED06974471531537 EUDAMED06974471531568 EUDAMED06974471531551 EUDAMED06974471531506 EUDAMED06974471531483 EUDAMED06974471531520 EUDAMED
- Basic UDI-DI
- 697447153169MD EUDAMED697447153151LS EUDAMED697447153160LT EUDAMED697447153163LZ EUDAMED697447153164M3 EUDAMED697447153153LW EUDAMED697447153156M4 EUDAMED697447153155M2 EUDAMED697447153150LQ EUDAMED697447153148M5 EUDAMED697447153152LU EUDAMED
- Direct Marketing DI
- 06974471531698 EUDAMED06974471531605 EUDAMED06974471531636 EUDAMED06974471531643 EUDAMED06974471531537 EUDAMED06974471531568 EUDAMED06974471531551 EUDAMED06974471531506 EUDAMED06974471531483 EUDAMED06974471531520 EUDAMED
- EMDN Code
- Z12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES EUDAMEDZ12020401,Z12020402 EUDAMEDZ12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMEDZ12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDRomania EUDAMEDHungary EUDAMEDFrance 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
Easyvistar by Shantou Easywell Electronic Technologies Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697447153169MD | 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 (11)
- EUDAMED 050cbadc-d133-4720-a58a-f38e03edaaac 61 fields · synced Aug 2, 2026
- EUDAMED 7e135171-0cc3-4a3c-a686-beef9b3d9324 61 fields · synced May 17, 2026
- EUDAMED 1fb7d789-b66f-4e7d-ba7b-559efb8fbe61 61 fields · synced May 17, 2026
- EUDAMED 65790f5e-dea3-4e87-84e5-4e996f8dde8d 61 fields · synced May 17, 2026
- EUDAMED a8374ec5-060c-4a40-8de9-4dbe8f087803 61 fields · synced May 17, 2026
- EUDAMED bf7a3c11-92d9-4953-86aa-1f21ee61a4a6 61 fields · synced May 17, 2026
- EUDAMED 9a101aac-3e67-49e1-aeb2-bffe276f5c1f 61 fields · synced May 18, 2026
- EUDAMED 040f8ac5-bf40-4613-9ecc-2e5cde77c092 61 fields · synced May 18, 2026
- EUDAMED 18a9b616-ade6-437c-948e-eb35c0702194 61 fields · synced May 18, 2026
- EUDAMED e358d90d-22fe-4392-aca7-ba21d215921d 61 fields · synced May 18, 2026
- EUDAMED d0e80be8-5c10-4635-8d7b-2fdf83e7c369 61 fields · synced May 19, 2026