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Disposable Electronic Flexible Ureteroscope

EUDAMED

Class IIa (EU MDR)

Ref UV-US100D-HModel UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H

by Shanghai SeeGen Photoelectric Technology Co., Ltd.

Identity

Device Name
Disposable Electronic Flexible Ureteroscope EUDAMED
Model / Reference
UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H EUDAMED
UV-US100D-H EUDAMED

Identifiers

Primary DI / UDI-DI
06973786290542 EUDAMED
Basic UDI-DI
697378629UV8N EUDAMED
EMDN Code
Z12020713 URETERORENOSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

Yes

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: Flexible video ureteroscope, single-use

Disposable Electronic Flexible Ureteroscope by Shanghai SeeGen Photoelectric Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED

Similar devices

Also classified as Flexible video ureteroscope, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000015374
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 11349a7f-839a-4190-b9dd-e8a00356c24a 61 fields · synced Jun 19, 2026