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4K Endoscopic Camera System

EUDAMED

Class I (EU MDR)

Ref SV-800NRef SV-800Ref SV-800RRef SV-800I

by Shenzhen Sophway Technology Co., Ltd.

Identity

Trade Name
4K Endoscopic Camera System EUDAMED
Device Name
4K Endoscopic Camera System EUDAMED
Model / Reference
SV-800N EUDAMED
SV-800 EUDAMED
SV-800R EUDAMED
SV-800I EUDAMED

Identifiers

Primary DI / UDI-DI
06973563040087 EUDAMED
06973563040001 EUDAMED
06973563040070 EUDAMED
06973563040063 EUDAMED
Basic UDI-DI
697356304SV-800JV 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
Poland 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

4K Endoscopic Camera System by Shenzhen Sophway Technology 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

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Manufacturer

Manufacturer
Shenzhen Sophway Technology Co., Ltd.
EUDAMED SRN
CN-MF-000027700
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (4)

  • EUDAMED 32a30f09-715b-48e7-b4a7-4bb575da3770 61 fields · synced Aug 2, 2026
  • EUDAMED 36818d85-1d23-438a-aa0f-ccf7979b8b77 61 fields · synced May 11, 2026
  • EUDAMED 8566fd1a-08ee-43c9-bc2d-8131d7d56039 61 fields · synced May 17, 2026
  • EUDAMED 972136bd-79be-42c3-8c19-845b7c6b3b78 61 fields · synced May 17, 2026