Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612018

FEI Number

3002809487

Entity Name

SAN-M PACKAGE CO., LTD.

City/State/Country

Shimada-city Shizuoka, JP

Establishment Address

1086-1 OJIRO, Shimada-city Shizuoka 428-0009, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SAN-M PACKAGE CO., LTD. (Owner Number: 8031533)

Owner / Operator Contact Address

1086-1 OJIRO, SHIMADA, JP-22 428-0009, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BARRIER Extra Protection Plus Face SOFLOOP Extra Protection Plus Face BARRIER Laser Plume Face Mask SOFLOOP Extra ProtectionPlus Face M SURGINE II Face Mask BARRIER Extra Protection Face Mask SOFLOOP Extra Protection Face Mask SURGINE II Soft Arch Mask SURGINE II Anti-Fog Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-02-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-02-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2008-02-26

Official Correspondent

Chito Hoshino

US Agent Details

Takahiro Haruyama Business: Globizz Corporation Email: register@globizz.net Phone: (310) 5383860

Related Public Records

Same Entity

SAN-M PACKAGE 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612018. Last updated year: 2026. Please use registration number 9612018 when referencing this establishment in official correspondence.