SeleneView®

FDA UDI

Class II (US FDA UDI)

by MacroLux Medical Technology Co., Ltd.

Identity

Trade Name: SeleneView® FDA UDI
Generic Name: Rigid video hysteroscope FDA UDI
Device Name: SeleneView®, Single-Use Digital Hysteroscope, HC35 FDA UDI
Model / Reference: HC35 FDA UDI
Description: SeleneView®, Single-Use Digital Hysteroscope, HC35 FDA UDI

Identifiers

Primary DI / UDI-DI: 06975339623180 FDA UDI
510(k) Number: K240978 FDA UDI
FDA Product Code: HIH FDA UDI
GMDN Term: Rigid video hysteroscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Rigid video hysteroscope

SeleneView® by MacroLux Medical Technology 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

K240978 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: MacroLux Medical Technology Co., Ltd.

Sources (1)

FDA UDI 256278e4-2a17-4a88-9f17-d05137258dda 34 fields · synced May 30, 2026