Vital Care Industries

Polyurethane, 7/8"D Tapered to 2.9"W x 11.8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long

Registry build 21.09.26
44manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
1recall

Who Else Makes It

Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITX
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Ming FAI Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Xuzhou Yongkang Electronic Science Technology Co., Ltd. Xuzhou Jiangsu Contract manufacturer 13
Hony Medical Co., Ltd. Taishan Guangdong Contract manufacturer 10
Xian Friendship Medical Electronics Co., Ltd. Xi’An Shaanxi Contract manufacturer 10
Taijia Medical Electronics (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Chison Medical Technologies Co., Ltd. Wuxi Jiangsu Contract manufacturer 5
Philips Ultrasound (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 5
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56

Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic

Record

Regulatory record for Vital Care Industries
Listed by Sheathing Technologies, Inc., United States
FDA product code ITX
Device type Transducer, Ultrasonic, Diagnostic
Device class Class 2
Regulation 21 CFR 892.1570
Establishment Repacker / relabeller, Manufacturer
Record published 2021-07-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date
Packaging Case of 6

Catalogue Numbers

Catalogue numbers for Vital Care Industries
Catalogue number Size Per pack Status
26303VCI 75 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
SonoScape Sonoscape Medical Corp. 302
Biopsy Starter Kit Civco Medical Instruments Co., Inc. 172
Sheathes Sheathing Technologies, Inc. 170
Needle Guide Civco Medical Instruments Co., Inc. 156
Sheathes3D Sheathing Technologies, Inc. 78
Ultrasound Probe Cover Biopsy Needle Guide Advance Medical Designs, Inc. 78
ultrasonic transducer Edan Instruments, Inc. 70
Unbranded Advance Medical Designs, Inc. 68
Reusable Biopsy Bracket Protek Medical Products, Inc. 60
Ultrasound Probe Cover Biopsy Needle Guide Kit Advance Medical Designs, Inc. 58
Biopsy Bracket Civco Medical Instruments Co., Inc. 56
Transducer Cover Civco Medical Instruments Co., Inc. 54

Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K153212 2016-03-04
K091828 2009-09-28
K043425 2005-02-28
K990175 1999-04-21

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity
2025-11-17 Class II Process control Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. 12

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