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ASAHI POLYSLIDER VIETNAM LLC

Viet Nam · Tan Thuan Ward H? Chi Minh

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 6 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States6 registration records, 2 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant · ASAHI POLYSLIDER VIETNAM LLC · ASAHI POLYSLIDER CO., LTD. · ASAHI POLYSLIDER COMPANY, LIMITED

FDA 510(k) clearances by year

22022 · K222084

FDA listed device types

Multiple Use Blood Lancet For Single Patient Use Only 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222084	OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie	2022-11-02
US	K221546	OneTouch Delica Plus Lancing System	2022-08-23
BR	80247640001	Onetouch Delica Plus Lancetador	Class I
BR	80247649001	Onetouch Delica Plus Lancetas	Class II

ASAHI POLYSLIDER VIETNAM LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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