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Medical Endoscopic Camera Systems And Cold Light Source

EUDAMED

Class I (EU MDR)

Ref E20A

by Shantou Easywell Electronic Technologies Co., Ltd.

Identity

Device Name
Medical Endoscopic Camera Systems And Cold Light Source EUDAMED
Model / Reference
E20A EUDAMED

Identifiers

Primary DI / UDI-DI
06974471531476 EUDAMED
Basic UDI-DI
697447153147M3 EUDAMED
EMDN Code
Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Romania 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

Medical Endoscopic Camera Systems And Cold Light Source by Shantou Easywell Electronic Technologies Co., Ltd. — Class I — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

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

Sources (1)

  • EUDAMED 53d7f938-64a6-4e0e-8257-2b8788760f9a 61 fields · synced Jun 19, 2026