FertiloScope

Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvaginal hydro-pelviscopy

Registry build 21.09.26
13manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (4), Guangdong (4), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HIH
Manufacturer City Province Registered as Device types
Guangdong MacroLux Medical Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 9
Peter’s Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Qingdao O-MEC Medical Technology Co., Ltd. Qingdao Shandong Contract manufacturer 6
Ningbo Skonsin Electronics Ltd. Ningbo Zhejiang Contract manufacturer 1
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Zhejiang Huanyi Sterilization Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 25
Macrolux Medical Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Guangzhou RED Pine Medical Instrument Co., Ltd. Guangzhou Guangdong Manufacturer 8
Shanghai AnQing Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 5
Guangdong EO Medical Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 5
Suzhou Acuvu Medical Technology Co., Ltd. Suzhou Jiangsu Specification developer 4
Jiangsu Jiyuan Medical Technology Co., Ltd. Taizhou Jiangsu Specification developer 3

Showing 12 of 13. All 13 manufacturers in China registered for Hysteroscope (And Accessories)

Record

Regulatory record for FertiloScope
Listed by viO HealthTech Limited, United Kingdom
FDA product code HIH
Device type Hysteroscope (And Accessories)
Device class Class 2
Regulation 21 CFR 884.1690
Establishment Specification developer, Manufacturer
Record published 2018-10-17
Record revised 2023-01-31 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
Distribution end date 2021-02-10

Catalogue Numbers

Catalogue numbers for FertiloScope
Catalogue number Size Status
FTO 1.40 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hysteroscope (And Accessories) Karl Storz GmbH & Co. KG 255
AED National Advanced Endoscopy Devices, Inc. 79
USA Elite Gyrus Acmi, Inc. 79
Olympus Olympus Winter & IBE Gmbh 57
Hysteroscope (And Accessories) Stryker GmbH 42
TruClear Covidien LP 29
Hysteroscopy sheath Sopro-Comeg GmbH 28
Hysteroscope (And Accessories) Richard Wolf Gmbh 24
Hysteroscope Sopro-Comeg GmbH 18
Elite 2 System Gyrus Acmi, Inc. 17
Gynecare Versapoint Ethicon, Inc. 16
USA Elite System Gyrus Acmi, Inc. 11

Showing 12 of 177. All products under Hysteroscope (And Accessories)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer