Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007963782

FEI Number

3007963782

Entity Name

Koo (Shanghai) Industries Co., Ltd

City/State/Country

Songjiang Shanghai, CN

Establishment Address

100 Zhongde Road, Xiaokunshan Town, Songjiang Shanghai 201614, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KOO MFG, INC. (Owner Number: 9012237)

Owner / Operator Contact Address

100 Zhongde Road, Dakun Indurstrial Park, Songjiang, CN-SH 201613, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elongated Non-Rebreather Oxygen Mask OXYGEN MASK, NON-REBREATHING Inflation Syringe for Rectal Balloon MASK INFLATION BULB BULB SYRINGES Oxygen Mask with Reservoir Bag face tent Drainage Bag with 'T' connector Drainage Bag Aerosol Mask Oxygen Mask Tracheostomy Mask ZEPHIR MASK BLUESTAR PLUS FACE MASK FISIOJET AEROSOL DELUXE NASAL MOONLIGHT NASAL First Breath Nasal Oxygen Cannula with ETCO2 monitoring First Breath Nasal Oxygen Cannula with gas monitoring line, male luer connector, tubing, oxygen adapter First Breath Nasal Oxygen Cannula with male luer connector, tubing and oxygen connector First Breath Nasal Oxygen Cannula with female luer connector, tubing and oxgyen adapter First Breath Nasal Oxygen Cannula with gas monitoring line, female luer connector, tubing, oxygen adapter OXYGEN NASAL CANNULA FACE MASK ARIA BLOW MOLD MASK CRYSTAL ANESTHESIA MASK OXYGEN TUBING Venturi Mask Venturi Oxygen Mask Tracheostomy Venturi Oxygen Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2005-07-29
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2006-04-27
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2005-07-29
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2005-07-29
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	1999-12-13
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-01-28
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2013-04-21

Official Correspondent

CHRISTOPHER KOO

US Agent Details

Matt Dryden Business: Promedic, LLC Email: matt.dryden@promedic.cc Phone: (239) 3076063

Related Public Records

Same Entity

KOO MFG, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9616410	KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD.	Songjiang Shanghai, CN

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007963782. Last updated year: 2026. Please use registration number 3007963782 when referencing this establishment in official correspondence.