Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019387954

FEI Number

3019387954

Entity Name

DIATRUST MEDICAL CO., LTD.

City/State/Country

Nanjing City Jiangsu, CN

Establishment Address

1001 Jingfeng Plaza, 1698, Shuanglong Avenue, Jiangning District, Nanjing City Jiangsu 211100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DiaTrust Medical Co., Ltd. (Owner Number: 10081862)

Owner / Operator Contact Address

1001 Jingfeng Plaza, 1698, Shuanglong Avenue, Jiangning District, Nanjing City, CN-JS 211100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDIA, MOUNTING, WATER SOLUBLE FORMULATIONS, PARAFFIN, ALL Flask, tissue culture SHAKER/STIRRER Applicator, absorbent tipped, sterile BOTTLE, COLLECTION, VACUUM MICROTOME, ACCESSORIES DEPRESSOR, TONGUE, NON-SURGICAL DISPENSER, LIQUID MEDICATION CASSETTES, TISSUE BLADE, SCALPEL DISH, TISSUE CULTURE TUBE, TISSUE CULTURE STAGES, MICROSCOPE FORCEPS BOTTLE, ROLLER, TISSUE CULTURE GIO / TUBE, COLLECTION, CAPILLARY BLOOD SYSTEM, SUSPENSION, CELL CULTURE CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE APPLICATOR, ABSORBENT TIPPED, NON-STERILE SCISSORS, GENERAL, SURGICAL UNIT, FILTER, MEMBRANE CryoTrust Vial CONTAINER, SPECIMEN, STERILE TUBE, SEDIMENTATION RATE DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC Tubing/tubing with filter, insufflation, laparoscopic CLAMP, UMBILICAL UNIT, DRYING HANDLE, SCALPEL CONTAINER, SPECIMEN, NON-STERILE DEVICE, ACCESSORY, COOLING PLATE FOR TISSUE EMBEDDING STATION MICRO PIPETTE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE SLIDES, MICROSCOPE DISPENSERS, PARAFFIN HEMOCYTOMETER BRUSH, BIOPSY, GENERAL & PLASTIC SURGERY SPECULUM, VAGINAL, NONMETAL TIMER, GENERAL LABORATORY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEQ	Media, Mounting, Water Soluble	Pathology	Class 1	864.4010	2021-08-19
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2021-08-06
KJA	Flask, Tissue Culture	Hematology	Class 1	864.2240	2021-08-19
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2024-11-14
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-06-01
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-11-14
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2021-07-20
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2024-11-14
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2024-11-14
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2021-08-06
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-11-14
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2021-08-19
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2021-08-19
KEJ	Stages, Microscope	Pathology	Class 1	864.3600	2024-11-14
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-11-14
KJC	Bottle, Roller, Tissue Culture	Hematology	Class 1	864.2240	2024-11-14
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2021-08-19
KJF	System, Suspension, Cell Culture	Hematology	Class 1	864.2240	2024-11-14
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2021-08-19
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2021-06-01
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-11-14
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2021-08-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2021-06-01
GHC	Tube, Sedimentation Rate	Hematology	Class 1	864.6700	2021-08-20
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2021-08-19
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2021-08-20
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2024-11-14
JRJ	Unit, Drying	Clinical Chemistry	Class 1	862.2050	2024-11-14
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-11-14
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-08-19
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2024-11-14
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2021-08-18
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2021-08-19
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2021-08-18
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2024-11-14
GHO	Hemocytometer	Hematology	Class 1	864.6160	2021-08-20
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2021-08-19
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2024-11-14
JBS	Timer, General Laboratory	Clinical Chemistry	Class 1	862.2050	2024-11-14

Official Correspondent

Nancy Wang

US Agent Details

Rafi Wong Business: PACIFIC FORTUNE MANAGEMENT INC. Email: pfmservice@pfmfinance.com Phone: (408) 3686359

Related Public Records

Same Entity

DiaTrust Medical 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K812750	Instrumentation Laboratory CO	IL 703, STAT SEPARATOR	1982-01-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019387954. Last updated year: 2026. Please use registration number 3019387954 when referencing this establishment in official correspondence.