Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010187826

FEI Number

3010187826

Entity Name

GUANGZHOU HUADA BIOTECHNOLOGY CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No.84, Banhe Road,Guangzhou High-Tech Industrial Development Zone, Guangzhou Guangdong 510530, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Guangzhou Huada Biotechnology Co., Ltd. (Owner Number: 10043265)

Owner / Operator Contact Address

No.84, Banhe Road,Guangzhou High-Tech Industrial Development Zone, Guangzhou, CN-GD 510530, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

60mm culture dish Center well dish Denuding pipettes Biopsy pipettes Sperm CD 4 well dish Holding pipettes 100mm culture dish Holding pipettes for PGT lCSl pipettes Sperm Collection Container 35mm culture dish lCSl dish CONFORMANT 2 EXU-DRY Skintegrity Hydrogel Wound Dressing Dora Disposable A.V. Fistula Needle Sets Collagen Wound Dressing Collagen Wound Dressing Denudation Pipettes IMPROVACUTER®Gel & Clot Activator Tube

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2024-11-27
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2017-03-20
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2020-07-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-12-16
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-01-07
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	Class 2	884.6130	2026-01-07
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-01-31

Official Correspondent

Yingjie Gu

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

Guangzhou Huada 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
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

Registration Number	Establishment Name	Location
3033740404	Guangzhou PINZHI Medical Device Co., Ltd.	Guangzhou Guangdong, CN
3040387472	UKS Medical Technology (Chongqing) Co., Ltd.	Chongqing, CN
1319660	ISOMEDIX OPERATIONS INC.	CHESTER, NY, US
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
3006405073	Sterigenics Denmark A/S	Espergaerde Sjalland, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010187826. Last updated year: 2026. Please use registration number 3010187826 when referencing this establishment in official correspondence.