Horizon Series™

-20°C / -30°C Laboratory Freezer - Undercounter, 5 cu ft

Registry build 21.09.26
9manufacturers in China registered for this device type
59catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (3), Anhui (2), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KSE
Manufacturer City Province Registered as Device types
Qingdao Haier Biomedical Co., Ltd. Qingdao Shandong Contract manufacturer 3
Infitek Co., Ltd. Shanghai Shanghai Manufacturer 49
Labpeak Co., Ltd. Jinan Shandong Manufacturer 43
Scitek Global Co., Ltd. Jinan Shandong Manufacturer 43
Aikang Medtech Co., Ltd. Shenzhen Guangdong Manufacturer 5
MVE Cryogenic Biological Equipment (Chengdu) Co., Ltd. Pidu District Chengdu Sichuan Manufacturer 3
Midea Biomedical Co., Ltd. Hefei Anhui Manufacturer 2
Zhejiang Heli Refrigeration Equipment Co., Ltd. Jinhua Zhejiang Manufacturer 1
Zhongke Meiling Cryogenics Company Limited. Hefei Anhui Manufacturer 1

Record

Regulatory record for Horizon Series™
Listed by Helmer Inc., United States
FDA product code KSE
Device type Refrigerator, Freezer, Blood Storage
Device class Class 2
Regulation 21 CFR 864.9700
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2019-01-31
Record revised 2021-08-18 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Latex Contains natural rubber latex
Label carries manufacturing date, serial number
Distribution end date 2021-08-17

Catalogue Numbers

Catalogue numbers for Horizon Series™
Catalogue number Size Status
HPR105-GX In distribution
HLR256-GX In distribution
HPR256 In distribution
HLF105 In distribution
HB456 In distribution
HB120 In distribution
HLR111 In distribution
HLR245 In distribution
HPR113-GX In distribution
HPR125 In distribution
HLR125 In distribution
HLF125-GX In distribution
HB256 In distribution
HBF105-GX In distribution
HBF125-GX In distribution
HB125 In distribution
HB225 In distribution
HLR105 In distribution
HLR125-GX In distribution
HBR245-GX In distribution
HLR113-GX In distribution
HLR120-GX In distribution
HLR256 In distribution
HPR226-GX In distribution
HBF120-GX In distribution
HPR456 In distribution
HBR113-GX In distribution
HPR256-GX In distribution
HPF125 In distribution
HPR120-GX In distribution
HLR105-GX In distribution
HB105 In distribution
HLF105-GX In distribution
HLR104-ADA In distribution
HLF104-ADA In distribution
HB111 In distribution
HPR245 In distribution
HPR225 In distribution
HLF125 In distribution
HBR120-GX In distribution
HBR226-GX In distribution
HPF104-ADA In distribution
HLF120 In distribution
HBR256-GX In distribution
HPR458-GX In distribution
HLR245-GX In distribution
HBR125-GX In distribution
HB104-ADA In distribution
HLF120-GX In distribution
HB245 In distribution
HPF120 In distribution
HPR120 In distribution
HBR105-GX In distribution
HPR245-GX In distribution
HPR125-GX In distribution
HLR120 In distribution
HBR458-GX In distribution
HPF105 In distribution
HPR111 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
B Medical Systems B Medical Systems Sarl 104
Follett Follett Corporation 97
i.Series® Helmer Inc. 69
Haier Qingdao Haier Biomedical Co., Ltd. 41
Thermo Scientific KEY Scientific Inc 29
Thermo Scientific Jewett Blood Bank Refrigerator KEY Scientific Inc 27
Thermo Scientific ™ CryoMed™ Thermo Fisher Scientific (Asheville) LLC 24
Biotecno Biotecno Industria E Comercio Ltda 23
Thermo Scientific TSX Series High-Performance Plasma Freezer KEY Scientific Inc 20
Thermo Scientific Forma Blood Bank Refrigerator KEY Scientific Inc 19
K2 Scientific, LLC K2 Scientific, LLC 19
Thermo Scientific Revco Freezer KEY Scientific Inc 19

Showing 12 of 73. All products under Refrigerator, Freezer, Blood Storage

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