Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031180757

FEI Number

3031180757

Entity Name

HUNAN PINLIU BIOLOGICAL TECHNOLOGY CO., LTD.

City/State/Country

CHANGDE CITY Hunan, CN

Establishment Address

Hunan Pinliu Biotechnology Industrial Park, Southeast Corner of the Intersection of Zhonglian Avenue, and Feilong West Road, Changde High-Tech Zone, Guanxi Town, Dingcheng District, CHANGDE CITY Hunan 415000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HUNAN PINLIU BIOLOGICAL TECHNOLOGY CO., LTD. (Owner Number: 10090342)

Owner / Operator Contact Address

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tape and bandage, adhesive (Foot pad; slimming patch; navel patch; detox foot patch; foot patch; warm foot patch; rheumatism patch) STEAM EYE MASK Waist Warmer, Knee Warmer, Steam Eye Mask, Visible Warm Eye Mask, Warm Foot Patch, Menstrual Warmer Patch Hot or Cold Disposable Pack, Hot or Cold Disposable Pad, Warm Patch, Heat Patch, Foot Warmer, Neck Warmer, Wrist Steam Patch, Hand & Foot Steam Patch, Ankle Steam Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-03-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-03-14
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-03-14

Official Correspondent

Huanling He

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HUNAN PINLIU BIOLOGICAL TECHNOLOGY 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
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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

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

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3014553350	CORRECT BREATHING CONCEPTS, LLC	Painesville, OH, US
3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031180757. Last updated year: 2026. Please use registration number 3031180757 when referencing this establishment in official correspondence.