Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017056269

FEI Number

3017056269

Entity Name

HBH BIOTECHNOLOGY LIMITED

City/State/Country

Yantai Shandong, CN

Establishment Address

No.97 Hou De road,Jinling Town,Zhaoyuan City, Yantai Shandong 265400, CN

Establishment Type(s)

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

Owner / Operator

HBH BIOTECHNOLOGY LIMITED (Owner Number: 10082686)

Owner / Operator Contact Address

No.97 Hou De road,Jinling Town,Zhaoyuan City, Yantai, CN-SD 265400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask Culture media Foam Swab,flocked swab,disposable sampling Swabs CENTRIFUGE-TD4C,TD4A,TD4B,TD4N,TD5,TD5A,TD5B,TD4,TXK4,TD6,TD6C,TGM12,TGW16,cytoprep-1,cytoprep-2 TG18A,TG20,TDL5,TDL5A,TDL5M,TGL16E,TGL16,TGL20,TGL18,DDL6,DL6MB,CDL7M,DL8M,GL12,GL21M,GL10 VTM Sampling Tube,Saliva Collection Kit,Specimen transport tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-09-09
JSF	Culture Media, Single Biochemical Test	Microbiology	Class 1	866.2320	2021-09-09
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-09-09
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2021-09-09
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2021-09-09

Official Correspondent

Yanqing Li

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

HBH BIOTECHNOLOGY LIMITED

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K822995	Granite Diagnostics, Inc.	ANDRADES FERMENTATION MEDIA	1982-11-16
K880126	Hardy Media	LAURYL TRYPTOSE BROTH	1988-03-31
K821594	Hardy Media	UREA AGAR SLANT	1982-07-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017056269. Last updated year: 2026. Please use registration number 3017056269 when referencing this establishment in official correspondence.