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Home›Japan›ASAHI POLYSLIDER COMPANY, LIMITED

ASAHI POLYSLIDER COMPANY, LIMITED

Japan · Maniwa
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Russia — 6 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
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 1 1Class 2a 1
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
Same-named companies — This database also contains companies with near-identical names: ASAHI POLYSLIDER VIETNAM LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Maniwa

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK222084OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie2022-11-02
USK221546OneTouch Delica Plus Lancing System2022-08-23
BR80247640001Onetouch Delica Plus LancetadorClass I
BR80247649001Onetouch Delica Plus LancetasClass II

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