Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616410

FEI Number

3003413553

Entity Name

KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD.

City/State/Country

Songjiang Shanghai, CN

Establishment Address

100 Zhongde Road, Building No.6, Xiaokunshan Town, Songjiang Shanghai 201614, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),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

Inflation Syringe for Rectal Balloon MASK INFLATION BULB BULB SYRINGES FACE MASK ARIA BLOW MOLD MASK CRYSTAL ANESTHESIA MASK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2006-04-27
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	1999-12-13

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
3007963782	Koo (Shanghai) Industries 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 9616410. Last updated year: 2026. Please use registration number 9616410 when referencing this establishment in official correspondence.