Aligned Medical Solutions

General Cysto Pack

Registry build 21.09.26
8manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Shandong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HCY
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zhejiang Medicines & Health Products I/ E Co., Ltd. Hangzhou Zhejiang Exporter 41
Anhui Dajiang Medical Products Co., Ltd. Chuzhou Anhui Manufacturer 12
Zhangzhou Aoxi Plastic Co., Ltd. Zhangzhou Fujian Manufacturer 7

Record

Regulatory record for Aligned Medical Solutions
Listed by Aligned Medical Solutions
FDA product code HCY
Device type Curette, Uterine
Device class Class 1
Regulation 21 CFR 884.4530
Premarket notification Exempt
Record published 2018-11-14

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 15 to 30 °C
Packaging Case of 10, case of 20, case of 8, case of 4, case of 3, case of 12

Catalogue Numbers

Catalogue numbers for Aligned Medical Solutions
Catalogue number Size Status
PSS3257D In distribution
AMS18223 In distribution
AMS16774 In distribution
AMS18225 In distribution
PSS3257E In distribution
AMS4001 In distribution
CMP1466A In distribution
AMS17574 In distribution
AMS4796A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 1,021
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 118
Aesculap Aesculap AG 105
Sklar® Sklar Corporation 85
Millennium Avalign Technologies, Inc. 78
Hayden Medical Hayden Medical Inc 68
Novo Surgical Inc. Novo Surgical, Inc. 67
Novo Surgical Novo Surgical, Inc. 50
Ambler Surgical Ambler Surgical, LLC 37
Integra® Miltex® Integra LifeSciences Production Corporation 36
V. Mueller Steris Corporation 34
MedGyn Uterine Curette Medgyn Products, Inc. 33

Showing 12 of 59. All products under Curette, Uterine

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