De Soutter Medical

ECO Pulse KIT- Shower Spray & FEM. TIP With Suction- Stryker

Registry build 21.09.26
17manufacturers in China registered for this device type
65catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (7), Beijing (4), Jiangsu (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FQH
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Elite Medtek(Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 9
Dongguan Kaiser Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 7
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Dongguan Hong De Medical Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 32
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Anqing Changfan Medical Instrument Co., Ltd. Anqing Anhui Manufacturer 9
Shenzhen Relish Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 9

Showing 12 of 17. All 17 manufacturers in China registered for Lavage, Jet

Record

Regulatory record for De Soutter Medical
Listed by DE Soutter Medical Ltd., United Kingdom
FDA product code FQH
Device type Lavage, Jet
Device class Class 2
Regulation 21 CFR 880.5475
Establishment Manufacturer
Premarket notification Exempt
Record published 2018-01-17
Record revised 2024-11-01 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 5, 5 of 5
Distribution end date 2026-06-29

Catalogue Numbers

Catalogue numbers for De Soutter Medical
Catalogue number Size Status
P30-707 In distribution
T20-172 In distribution
T20-102 In distribution
P30-122 In distribution
P30-709 In distribution
P31-707 In distribution
T20-121 In distribution
P31-709 In distribution
P30-123 In distribution
T20-170 In distribution
T20-173 In distribution
P30-705 In distribution
T20-100 In distribution
T20-110 In distribution
P30-700 In distribution
P30-704 In distribution
P30-710 In distribution
T20-171 In distribution
P31-702 In distribution
P30-124 In distribution
T20-122 In distribution
P30-121 In distribution
P30-701 In distribution
P31-710 In distribution
P30-125 In distribution
P30-120 In distribution
P30-711 In distribution
P30-702 In distribution
P30-127 In distribution
P31-711 In distribution
P20-702 Withdrawn
P20-126 Withdrawn
P20-700 Withdrawn
P20-120 Withdrawn
P20-107 Withdrawn
P20-104 Withdrawn
P31-700 Withdrawn
P20-704 Withdrawn
P20-106 Withdrawn
T10-102 Withdrawn
P31-701 Withdrawn
P20-707 Withdrawn
P31-708 Withdrawn
P20-100 Withdrawn
P20-101 Withdrawn
P20-125 Withdrawn
P20-105 Withdrawn
P20-103 Withdrawn
T10-100 Withdrawn
T20-101 Withdrawn
P20-122 Withdrawn
P20-703 Withdrawn
P20-706 Withdrawn
P20-708 Withdrawn
P20-108 Withdrawn
P30-708 Withdrawn
T10-103 Withdrawn
P31-705 Withdrawn
P20-705 Withdrawn
P20-123 Withdrawn
P20-124 Withdrawn
P20-701 Withdrawn
P31-704 Withdrawn
P20-121 Withdrawn
P20-102 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
InterPulse Stryker GmbH 41
Lavage, Jet Stryker GmbH 40
Pulsavac® Zimmer Orthopaedic Surgical Products 35
MicroAire® Microaire Surgical Instruments LLC 34
Cleanest Guangzhou Clean Medical Products Manufacturing Corp 32
Simpulse Davol Inc. 31
AWI Apex (Suzhou) Medical Products Company 27
CarboJet® CO2 Bone Lavage System Kinamed, Inc. 26
Zksk Beijing Zksk Technology Co., Ltd. 20
Erbe Erbe Elektromedizin GmbH 18
AWI Apex (Guangzhou) Tools & Orthopedics Company 18
debritom+ Medaxis AG 17

Showing 12 of 98. All products under Lavage, Jet

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