GynoVision

FDA UDI

Class II (US FDA UDI)

by Chongqing Jinshan Science & Technology (Group) Co., Ltd

Identity

Trade Name: GynoVision FDA UDI
Generic Name: Rigid video hysteroscope FDA UDI
Device Name: Image recorder, 1 pack FDA UDI
Model / Reference: JSX-1 FDA UDI
Description: Image recorder, 1 pack FDA UDI

Identifiers

Primary DI / UDI-DI: 06946332802117 FDA UDI
510(k) Number: K172151 FDA UDI
FDA Product Code: HGH FDA UDI
GMDN Term: Rigid video hysteroscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.5070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Rigid video hysteroscope

GynoVision by Chongqing Jinshan Science & Technology (Group) Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid video hysteroscope.

EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
HTx Jednorazowy Histeroskop — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
Hysteroscope — Innoview GmbH · Class IIa
EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
HYSTEROSCOPE — Henke-Sass, Wolf GmbH · Class IIa
Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
Histeroscópio Descartável HTx — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa

Cleared under the same submission

K172151 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Chongqing Jinshan Science & Technology (Group) Co., Ltd

Sources (1)

FDA UDI 4ee7b050-99c6-4658-bea3-761870d22f77 36 fields · synced May 31, 2026