Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033815621

FEI Number

3033815621

Entity Name

GUANGDONG HUANKAI BIOLOGY SCI.&TECH.CO.,LTD

City/State/Country

Zhaoqing Guangdong, CN

Establishment Address

No. 13 Middle Keji Street, High-Tech Industrial Development Zone, Zhaoqing Guangdong 526238, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGDONG HUANKAI BIOLOGY SCI.&TECH.CO.,LTD (Owner Number: 10091596)

Owner / Operator Contact Address

No. 13 Middle Keji Street, High-Tech Industrial Development Zone, Zhaoqing, CN-GD 526238, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Handy Plate® Staphylococcus aureus Confirmation Disk Chromogenic Yersinia Enterocolitica Agar Chromogenic Vibrio Agar Handy Plate® Staphylococcus Aureus Count Plate SS Agar Cronobacter (Enterobacter Sakazakii) Chromogenic Agar Handy Plate® Salmonella Count Plate MacConkey Agar (Without Salt) Chromogenic Shigella Agar Tryptone Bile X-glucuronide Agar Chromogenic Listeria Agar Multiple Enzyme Substrate Medium Eosin Methylene Blue Agar Chromogenic Bacillus Cereus Agar Xylose Lysine Desoxycholate Agar MacConkey Agar Chromogenic L.monocytogenes Agar Agar Listeria according to Ottaviani and Agosti Chromogenic Candida Agar Chromogenic Coliform Agar MacConkey Agar NO.3 Chromogenic Vibrio cholerae Agar Hektoen Enteric Agar Chromogenic E.coli O157 Agar Handy Plate® E.coli & Coliform(ECC) Detection Plate Chromogenic Staph.aureus Agar Chromogenic E.Coli Agar Handy Plate® Salmonella Confirmation Disk Chromogenic Salmonella Agar Violet Red Bile Glucose Agar Chromogenic Coliform & E.coli(ECC) Agar Handy Plate® Cronobacter Detection Plate TSAWLP Plate (TSA with Lecithin and Tween-80) Handy Plate® Mold & Yeast Count Plate R2A(90mm)Plate IRRAD with 3 WRAP Mueller Hinton Agar Rappaport-Vassiliadis Salmonella Enrichment Broth Half-Fraser Broth(Without Ferric Ammonium Citrate) Potato Dextrose Agar NA Contact Plate IRRAD with 3 WRAP Columbia Agar Base Handy Plate® Aerobic Count Plate 0.1% Peptone Water Listeria Enrichment Broth Base (UVM Formulation) R2A Broth NA(90mm)Plate IRRAD with 3 WRAP Presence-Absence Broth Trypticase (Tryptic) Soy Broth (Soybean Casein Digest Medium) TSA(90mm)Plate IRRAD with 3 WRAP CLED Medium (With Andrade Indicator) Mueller Hinton Broth Nutrient Broth Buffered Peptone Water GC Agar Base TSAWLP Contact Plate(TSA with Lecithin and Tween-80) LB Broth(Lennox) LB Agar(Lennox) Triple Sugar Iron Agar SDA(90mm) Plate IRRAD with 3 WRAP Fluid Thioglycollate Medium II Handy Plate® Coliform Count Plate Fraser Broth Base Handy Plate® Rapid Aerobic Count Plate SDA Contact Plate IRRAD with 3 WRAP Linden Grain Medium (LG Medium) Brain Heart Infusion Broth Sabouraud Dextrose Agar Blood Agar Base Nutrient Agar PALCAM Agar Base Mueller Hinton Agar No.2 Plate Count Agar Tryptic Soy Agar(Soybean Casein Digest Agar) Buffered Sodium Chloride Peptone Solution, pH7 R2A Agar Urea Broth Base Iron Sulphite Agar(Modified Cameron Sulphite Agar) TSA Contact Plate IRRAD with 3 WRAP Handy Plate® Rapid Mold & Yeast Count Plate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2024-10-17
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2024-10-17

Official Correspondent

Yu Wei Wu

US Agent Details

Andy Smith Business: GRZAN GROUP INC. Email: info@grzan-ar.com Phone: (332) 2015192

Related Public Records

Same Entity

GUANGDONG HUANKAI BIOLOGY SCI.&TECH.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
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03
K811644	Hardy Media	HEKTOEN ENTERIC AGAR	1981-07-02
K832535	Otisville Biotech, Inc.	HEKTOEN ENTERIC AGAR PLATE	1983-10-04
K811331	Acumedia Manufacturers, Inc.	SF BROTH	1981-05-29
K872058	Orion Corp.	ORICULT-N CULTURE-PADDLE	1987-06-10

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2016672	KEY SCIENTIFIC PRODUCTS	Stamford, TX, US
8023060	BIO-RAD	STEENVOORDE Nord, FR
9610649	MEDICAL WIRE AND EQUIPMENT CO. LTD.	CORSHAM, WILTSHIRE, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033815621. Last updated year: 2026. Please use registration number 3033815621 when referencing this establishment in official correspondence.