Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008693666

FEI Number

3008693666

Entity Name

HEBEI HOUDE HANFANG MEDICAL DEVICES GROUP CO.,LTD

City/State/Country

Shijiazhuang City Hebei, CN

Establishment Address

Beisun Houdehanfang Industrial Park, No.1, Zhengxing Road, Zhengding County, Shijiazhuang City Hebei 050800, CN

Establishment Type(s)

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

Owner / Operator

HEBEI HOUDE HANFANG MEDICAL DEVICES GROUP CO.,LTD (Owner Number: 10033948)

Owner / Operator Contact Address

Beisun Houdehanfang Industrial Park, No.1, Zhengxing Road, Zhengding County, Shijiazhuang City, CN-HE 050800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCAR REPAIR PATCH SCAR SHEET SILICONE PATCH SCAR TAPE SILICONE GEL SHEET SOFT SILICONE SCAR TAPE FEVER COOLING PATCH HYDROGEL PATCH FOOT MASK FOOT PATCH SLIMMING PATCH Health Patch MOUTH TAPE ADHESIVE PATCH Absorbent Pad/Adhesives

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2022-08-11
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2024-01-02
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-01-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2010-10-21
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-07-12

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

HEBEI HOUDE HANFANG MEDICAL DEVICES GROUP 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

Similar Registrations

Registration Number	Establishment Name	Location
2950792	BIODERMIS LLC	Henderson, NV, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3009192857	Neodyne Biosciences, Inc.	Fremont, CA, US
3005857283	PRECO, LLC	Somerset, WI, US
3019769561	ScarPro NV	Aalter Flanders, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008693666. Last updated year: 2026. Please use registration number 3008693666 when referencing this establishment in official correspondence.