Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018366470

FEI Number

3018366470

Entity Name

MCREAT ( GUANGZHOU ) BIO-TECH CO.,LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

3rd Floor, B14 Huachuang Industry Area, No. 9 Huateng Road, Jinshan Cun, Shiji Town Panyu District, Guangzhou Guangdong 511450, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MCREAT (GUANGZHOU) BIO-TECH CO.,LTD (Owner Number: 10081029)

Owner / Operator Contact Address

3rd Floor, B14 Huachuang Industry Area, No. 9 Huateng Road, Jinshan Cun, Shiji Town Panyu District, Guangzhou, CN-GD 511450, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endotracheal Intubation Stylet (6fr,8fr,10fr,12fr,14fr) Laryngeal Mask Airway (1,1.5,2,2.5,3,4,5) Suction Toothbrush (Adult) Medical Pressure Infusor Bags (500mL,1000mL) Endotracheal Tube Holder (CHILD, ADULT) Disposable Breathing Circuit Gabriel Feeding Tube with Balloon (6fr,10fr,12fr,14fr,16fr) Suction Liner System (Suction Liner Bag, Suction Liner Canister, Suction Tube) (1500mL,2000mL,2500mL) Closed Suction Catheter (5fr,6fr,7fr,8fr,10fr,12fr,14fr,16fr,18fr)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2023-07-31
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2023-07-31
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-03-29
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2021-03-11
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2023-07-31
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2021-03-11
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2021-06-30
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2021-06-30
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-03-29
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2021-03-11

Official Correspondent

Zhang Weiyuan

US Agent Details

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

Related Public Records

Same Entity

MCREAT (GUANGZHOU) BIO-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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018366470. Last updated year: 2026. Please use registration number 3018366470 when referencing this establishment in official correspondence.