Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018296904

FEI Number

3018296904

Entity Name

ZHONGKE MEILING CRYOGENICS COMPANY LIMITED.

City/State/Country

Hefei Anhui, CN

Establishment Address

No.1862 Zishi Road, Economic Development Zone, Hefei, Anhui, China, Hefei Anhui 230601, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhongke Meiling Cryogenics Company Limited. (Owner Number: 10079812)

Owner / Operator Contact Address

No.1862 Zishi Road, Economic Development Zone, Hefei, Anhui, China, Hefei, CN-AH 230601, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultra-low Temperature Freezer DW-HL218, DW-HL398, DW-HL528, DW-HL678, DW-HL778, DW-HL858, DW-HL1008 Ultra-low Temperature Freezer DW-FL90, DW-FL270, DW-FL45, DW-FL528, DW-FL528C, DW-FL628F, DW-FL678 Ultra-low Temperature Freezer DW-HL110V, DW-HL398S, DW-HL528S, DW-HL528S, DW-HL678S, DW-HL778S, DW-HL858S, DW-HL1008S Solar direct drive ice-lined refrigerator TC-125WSDD Ultra-low Temperature Freezer DW-HL398SA, DW-HL528SA, DW-HL678SA, DW-HL778SA, DW-HL858SA, DW-HL1008SA Pharmacy Refrigerator YC-55EL, YC-56EL, YC-130EL, YC-315EL, YC-395EL, YC-525EL, YC-650EL, YC-725EL, YC-1320EL Ultra-low Temperature Freezer DW-HL50HC, DW-HL100HC, DW-HL218HC Blood Bank Refrigerator XC-90W, XC-130L, XC-170L, XC-168L, XC-380L, XC-268L, XC-630L, XC-618L, XC-1378L, XC-1380L Combined refrigerator and freezer YCD-FL289, YCD-EL300, YCD-EL450, YCD-FL300, YCD-FL450, YCD-FL519 Ultra-low Temperature Freezer DW-HL1.8, DW-HL50, DW-HL100, DW-HL340, DW-HL428, DW-HL578, DW-HL708 Ultra-low Temperature Freezer DW-UW258, DW-UW128, DW-ZW128, DW-UW128C Ultra-low Temperature Freezer DW-HL398D, DW-HL528D, DW-HL678D Pharmacy Refrigerator YC-650CL, YC-650CEL, YC-1320CL, YC-1320CEL Ultra-low Temperature Freezer DW-HL398M, DW-HL528M, DW-HL678M, DW-HL778M, DW-HL858M, DW-HL1008M Ultra-low Temperature Freezer DW-HL530, DW-HL780, DW-HL428T, DW-HL578T, DW-HL778T, DW-HL848T, DW-HL1008T Pharmacy Refrigerator YC-400L, YC-525L, YC-650L, YC-725L, YC-1015L, YC-1320L, YC-1505L, YC-1500L Ultra-low Temperature Freezer DW-HL398HC, DW-HL528HC, DW-HL678HC, DW-HL778HC, DW-HL858HC, DW-HL1008HC Ultra-low Temperature Freezer DW-FL778, DW-FL778C, DW-FL1008, DW-FL1008C, DW-FW270, DW-FW360 Pharmacy Refrigerator YC-55L, YC-75L, YC-75EL, YC-110L, YC-130L, YC-130CL, YC-300L, YC-315L, YC-395L Biomedical freezer DW-XL90, DW-XL668 Ultra-low Temperature Freezer DW-HW50, DW-HW50HC, DW-HL528G, DW-HW138, DW-HW328, DW-HW668 Ice-lined Refrigerator YC-125EW, YC-150EW, YC-275EW Biomedical freezer DW-YL90, DW-YL270, DW-YL450

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	2021-02-14

Official Correspondent

Yun Liu

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Zhongke Meiling Cryogenics Company Limited.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3022121584	ZHEJIANG HELI REFRIGERATION EQUIPMENT CO., LTD.	Jinhua Zhejiang, CN
3019916040	NUVE SANAYI MALZEMELERI IMALAT VE TICARET A.S.	ANKARA, TR
3027645317	INFITEK CO., LTD.	Shanghai, CN
3017882410	BIOTECNO INDUSTRIA E COMERCIO LTDA	SANTA ROSA Rio Grande do Sul, BR
3004973569	HELMER Inc.	NOBLESVILLE, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018296904. Last updated year: 2026. Please use registration number 3018296904 when referencing this establishment in official correspondence.