Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012858319

FEI Number

3012858319

Entity Name

QINGDAO HAIER BIOMEDICAL CO., LTD

City/State/Country

Qingdao Shandong, CN

Establishment Address

No.280 Fengyuan Road, High-tech Zone, Qingdao(266111), P.R.China, Qingdao Shandong 266101, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Qingdao Haier Biomedical Co., Ltd (Owner Number: 10058509)

Owner / Operator Contact Address

No.280 Fengyuan Road, High-tech Zone, Qingdao(266111), P.R.China, Qingdao, CN-SD 266111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultra Low Temperature(ULT)Freezer DW-86L338J,DW-86L578J,DW-86L728J,DW-86L338JA,DW-86L490JA,DW-86L578JA Ultra Low Temperature(ULT)Freezer DW-86L578ST,DW-86L728ST,DW-86L828J Ultra Low Temperature(ULT)Freezer DW-86L579BPT,DW-86L579BP,DW-86L729BPT,DW-86L729BP,DW-86L829BPT,DW-86L829BP DEEP FREEZER DW-25L92,DW-25L262,DW-30L508,DW-30L528D Deep Freezer DW-40L818BP,DW-40L959BP Ultra Low Temperature(ULT)Freezer DW-86W420JA Blood Bank Refrigerator HXC-149,HXC-149T,HXC-149R,HXC-429,HXC-429T,HXC-429R Ultra Low Temperature(ULT)Freezer DW-86L728JA,DW-86L828JA Blood Bank Refrigerator HXC-629B,HXC-629TB,HXC-629RB Ultra Low Temperature(ULT)Freezer DW-86L100J Ultra Low Temperature(ULT)Freezer DW-86L626 Ultra Low Temperature(ULT)Freezer DW-86L51J Ultra Low Temperature(ULT)Freezer DW-86L578BPST,DW-86L728BPST,DW-86L828BPST Blood Bank Refrigerator HXC-629,HXC-629T,HXC-629R,HXC-1369,HXC-1369T Ultra Low Temperature(ULT)Freezer DW-80WZ15 Ultra Low Temperature(ULT)Freezer DW-86L730BPT,DW-86L830BPT Cryogenic Freezer DW-150W209A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2018-10-05

Official Correspondent

dunhuang Zhuang

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Qingdao Haier Biomedical Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012858319. Last updated year: 2026. Please use registration number 3012858319 when referencing this establishment in official correspondence.