Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031690

FEI Number

1000600761

Entity Name

ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant

City/State/Country

Maniwa Okayama, JP

Establishment Address

860-2 Misaki, Maniwa Okayama 719-3226, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ASAHI POLYSLIDER COMPANY, LIMITED (Owner Number: 10026630)

Owner / Operator Contact Address

3-3-3 Nakanoshima, Kita-Ku, Osaka, JP-27 530-0005, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222084

PMA Number

N/A

All Registered Proprietary Names

Accu-Chek Softclix OneTouch Delica Plus Lancets OneTouch Delica Plus Lancing Device Accu-Chek Safe-T-Pro Plus Assure Lance Assure Lance Plus OneTouch Delica Safety HemoCue Safety Lancet Capiject Safety Lancet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-06-08
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-08-31
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2022-08-31
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-06-08
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2022-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Greg Lamps Business: APS America LLC Email: Glamps@Asahi-Us.Com Phone: (678) 6015370

Related Public Records

Same Entity

ASAHI POLYSLIDER COMPANY, LIMITED

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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031690. Last updated year: 2026. Please use registration number 8031690 when referencing this establishment in official correspondence.