Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026593440

FEI Number

3026593440

Entity Name

HEBEI FEIFAN BIOTECHNOLOGY CO.,LTD.

City/State/Country

Shijiazhuang Hebei, CN

Establishment Address

North Of Anxia Village, Zhengding County, Shijiazhuang Hebei 050800, CN

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hebei Feifan Biotechnology Co.,Ltd. (Owner Number: 10087290)

Owner / Operator Contact Address

North Of Anxia Village, Zhengding County, Shijiazhuang, CN-HE 050800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cold /Cooling patch/pack: 6.6*16.3, 6.5*17, ?7, 7.5*14.5, 7*16, 8*8, 8*13, 8.5*14.5, 10*13.5, 10*20cm Cold /Cooling patch/pack: 3*8.5, 4*8.5, 4*11, 4.5*11, 4.3*12, 5*12, 5*17, 5.5*23, 5*9.5, 5.5*13.5, 5.5*20, 6*6, 6*8.5 Warmer patch: 6*6, 6*8, 5.5*9, 7*9.5, 7.5*23, 8*9, 8*10, ?6, ?8, ?12, 8*11.5, 8*19, 8*20, 8*23, 8*24, 8.5*25, 8.5*27 Warmer patch: 9.5*11.5, 9.5*13, 9.5*15.5, 9.5*19, 9*52, 15*106, 9.5*14, 9.5*30, 10*13, 10*30, 10.7*51, 12*12, 12*14.5 Warmer patch: 13.5*16.5, 11.5*20, 12*12, 9.5*11.5, 14*20, 14*21.5, 15*27.5, 27*31.5, 31.5*41, 26*60cm cooling eye mask: 8*19cm Shipping heat pack: 9.5*14, 9.5*19.5, 12*14, 13.5*16.5, 11.5*12, 11.5*16.5, 11.5*20cm Disposable self -heating pack Steam eye mask: 8*19 Health patch: 7.6*2, 7.5*11, 9*6cm Pain Relief Patch: 10*12.5, 7.5*7.5, 8*6.7, 9.5*9.5, 6.6*6.6, 7*7cm Nasal Strips: 7*2.6, 7.6*2.2, 5.2*2.2cm Hand /Foot Mask: 24*27.5, 34*23 Health patch: 4*5.5, 4.3*6, 4.8*7.5, 5*3.2, 5*3.4, 5.2*3, 8.9*3.8, 4.5*4.5, 7.2*2.3, 8*4, 7.6*3.8, 8.3*4.5, 9*4.8 Slimming patch: 6*6, 7*10, 20*31 Foot patch: 6*8, 9.5*12, 10*13cm Health patch: 8.5*3.7, 7*3.8, 7.6*4.1, 7.8*4.2, 7.5*4.5, 9.5*3.6, ?6,3*3, ?3, ?2, 2.5*2.5, 9*9, 2*4, 7.5*1, 2.9*2, 5*5 Nasal Strips: 6*2.2, 6.6*1.9, 6.2*2.2, 6*2.1, 6.1*1.8, 6.1*2.2, 5.7*2.3, 5.5*1.7, 5.5*1.6, 4.4*1, 4.4*1.5, 5.6*1.8

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2023-02-09
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-12-19
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2023-02-09
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-02-08

Official Correspondent

Jason Zhang

US Agent Details

JACLINE BOBOIGE Email: boboigechen@gmail.com Phone: (414) 9442888

Related Public Records

Same Entity

Hebei Feifan Biotechnology Co.,Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3042148166	CAM THANH TOY COMPANY LIMITED	Vu Ban District Nam Dinh, VN
3003079019	KOBAYASHI AMERICA MANUFACTURING, LLC	Dalton, GA, US
3011182985	Kunshan Topgel Industry Co., Ltd	Kunshan Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026593440. Last updated year: 2026. Please use registration number 3026593440 when referencing this establishment in official correspondence.