Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007695715

FEI Number

3007695715

Entity Name

FOREFRONT (XIAMEN) MEDICAL DEVICES CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

No.28 Haijing East Road & No.61 Haijing South Road, Xiamen Area of China (Fujian)Pilot Free Trade Zone, Xiamen Fujian 361026, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Forefront (Xiamen) Medical Devices Co., Ltd. (Owner Number: 10029104)

Owner / Operator Contact Address

No.28 HAIJING EAST ROAD & NO.61 HAIJING SOUTH ROAD, XIAMEN AREA OF CHINA (FUJIAN) PILOT FREE TRADE ZONE, Xiamen, CN-FJ 361026, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

M1 CAPNOGRAPHY MASK Soviflex self-retaining vaginal retractor LMA Laryngeal Mask Airway, Unique,Flexible, Fastract, LMA Proseal, LMA Classic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2019-05-22
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-01-24
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-01-24
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2023-12-26
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2009-04-05

Official Correspondent

Kelly Chen

US Agent Details

Mark Gauvain Email: mark.gauvain@forefrontmedical.com Phone: (978) 8042279

Related Public Records

Same Entity

Forefront (Xiamen) Medical Devices 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

Similar Registrations

Registration Number	Establishment Name	Location
3014647261	RETRACT EEZ, INC.	Largo, FL, US
3033892080	TALENT TECHNOLOGY MOULD CO., LIMITED	Shenzhen Guangdong, CN
1315756	Weco Manufacturing Group-Henrietta	Rochester, NY, US
3036269993	GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD	Nanning Guangxi, CN
3011585752	HANGZHOU HAIZHU MIM PRODUCTS CO., LTD	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007695715. Last updated year: 2026. Please use registration number 3007695715 when referencing this establishment in official correspondence.