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Single-use Digital Hysteroscope

EUDAMED

Class IIa (EU MDR)

Ref GYUT-A12.6-12Model GYUT-B15-30

by Zhejiang Geyi Medical Instrument Co., Ltd.

Identity

Device Name
Single-use Digital Hysteroscope EUDAMED
Model / Reference
GYUT-B15-30 EUDAMED
GYUT-A12.6-12 EUDAMED

Identifiers

Primary DI / UDI-DI
06925830113451 EUDAMED
Basic UDI-DI
69258301GYDBTZ EUDAMED
EMDN Code
Z12020704 HYSTEROSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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: Rigid video hysteroscope

Single-use Digital Hysteroscope by Zhejiang Geyi Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Rigid video hysteroscope.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Zhejiang Geyi Medical Instrument Co., Ltd.
EUDAMED SRN
CN-MF-000020887
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (1)

  • EUDAMED 524f05cf-6561-45c4-8a3b-cd1796256421 61 fields · synced Jun 19, 2026