Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028536560

FEI Number

3028536560

Entity Name

ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

688 Bin'an Road, Building 2E, 2/F, Room 243, Hangzhou Zhejiang 310051, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

OriGyn Medical Technology (Hangzhou) Co., Ltd (Owner Number: 10091314)

Owner / Operator Contact Address

688 Bin'an Road, Building 2E, 2/F, Room 243, Hangzhou, CN-ZJ 310051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240401

PMA Number

N/A

All Registered Proprietary Names

Scissors Biopsy forceps Grasping Forceps Separating forceps ClearVision Single Use Hysteroscope & Image Processing System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2024-12-06
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-08-21

Official Correspondent

Ting Lou

US Agent Details

Boyle Wang Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

OriGyn Medical Technology (Hangzhou) Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

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3029929134	MACROLUX MEDICAL TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028536560. Last updated year: 2026. Please use registration number 3028536560 when referencing this establishment in official correspondence.