Ultra Clean Systems

33 catalogue numbers from Model 1101 - Lumen Tray with Accessory k, listed by Getinge Disinfection AB, Sweden, under Cleaner, Ultrasonic, Medical Instrument. 48 manufacturers in China are registered for this product code.

Registry build 21.09.26
48manufacturers in China registered for this device type
33catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (26), Zhejiang (7), Jiangsu (5). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FLG
Manufacturer City Province Registered as Device types
Shenzhen Heearly Technology Co., Ltd. Bao An District, Shenzhen Guangdong Contract manufacturer 13
Foshan Nanhai Plus Medical Co Ltd Foshan Guangdong Contract manufacturer 12
Xiamen Atyou Health Technology Co., Ltd. Xiamen Fujian Contract manufacturer 2
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Tribest Dental Products Co Ltd Yangzhong Jiangsu Contract manufacturer 58
Dongguan Wanjin Industrial Co., Ltd. Dongguang Guangdong Remanufacturer 41
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Ningbo Just Soon Industrial Limited Ningbo Zhejiang Repacker / relabeller 36
Jinyuan Medical Equipment(Tianjin)Co., Ltd. Tianjin Tianjin Contract manufacturer 27
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Zhengzhou Huaer Electro-Optics Technology Co., Ltd. Zhengzhou Henan Contract manufacturer 21

Showing 12 of 48. All 48 manufacturers in China registered for Cleaner, Ultrasonic, Medical Instrument

Record

Regulatory record for Ultra Clean Systems
Listed by Getinge Disinfection AB, Sweden
FDA product code FLG
Device type Cleaner, Ultrasonic, Medical Instrument
Device class Class 1
Regulation 21 CFR 880.6150
Establishment Manufacturer
Premarket notification Exempt
Record published 2026-05-11

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Ultra Clean Systems
Catalogue number Size Status
Model 1101 – Lumen Tray with Accessory kit In distribution
XI ADAPTERS R2 – 10PK In distribution
SP Tray with adapters – Model 1101 In distribution
BASKET ASSEMBLY, TRITON 36, 72 10-0158 In distribution
RAC Xi TRAY,TRITON 10-0324 In distribution
Xi RACS tray with adapters for Model 1101 In distribution
Model 1101 RACS tray with S and SI adapters In distribution
D5 ADAPTERS 6PK In distribution
BASKET ASSEMBLY, 1150, 1522 10-0155 In distribution
Model 1100 – Lumen tray only In distribution
BASKET W/ADAPTER KIT, 36, 72 10-0158 In distribution
Xi RACS tray with adapters for Model 1101 In distribution
Getinge 1522 In distribution
TRITON_WIRE MESH_BARCODE TAG ASSEMBLY In distribution
ROBOTIC ARM CLEANING BASKET 10-0312 In distribution
UDI LABEL D5 ADAPTER 1 In distribution
Getinge Triton 72 In distribution
Getinge 1100 In distribution
X/XI ADAPTERS 6PK In distribution
RACS BASKET, Xi ADAPTERS 10-0324 In distribution
ADAPTERS,TRITON XI,10 PACK In distribution
Getinge 1101 In distribution
D5 ADAPTERS 10PK In distribution
WIRE MESH BASKET In distribution
BASKET W/ADPTR KIT, 1150/1522 10-0025 In distribution
Getinge Triton 36 In distribution
Model 1100 – Lumen Tray with Accessory Kit In distribution
SP ADAPTER & HOSE ASS. KIT In distribution
RAC Xi TRAY,TRITON W/SP ADPTRS 10-0324 In distribution
XI ADAPTERS R2 – 6PK In distribution
Getinge 1150 In distribution
Model 1101 – Lumen Tray only In distribution
RACS BASKET, S/SI ADAPTERS 10-0158 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
BioSonic Coltene/Whaledent Gmbh & Co. KG 49
Prolystica Steris Corporation 41
Henry Schein Henry Schein, Inc. 33
Steelco Steelco SPA 16
BrandMax Tri-Clean Brandmax 12
Alconox Alconox, LLC 11
Valsure Steris Corporation 11
Darby Dental Supply, LLC Darby Dental Supply, LLC 10
Detojet Alconox, LLC 9
Liquinox Alconox, LLC 8
Citranox Alconox, LLC 8
Tergazyme Alconox, LLC 8

Showing 12 of 834. All products under Cleaner, Ultrasonic, Medical Instrument

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