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SP MANUFACTURING PTE LTD

Indonesia · Batam Riau

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 2 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

16listed device types

Class I 8Class II 7Class III 0unclassified 1

plus 28 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

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 States28 registration records, 0 510(k), 0 PMA, 65 excluded

Brazil0 confirmed, 41 excluded

Saudi Arabia1 confirmed, 33 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: Stryker Poland Manufacturing Sp. z o.o. · Solventum Poland Manufacturing SP. ZO.O · 3M POLAND MANUFACTURING SP. Z O.O · PT. SP Manufacturing · 3M Poland Manufacturing Sp.z o.o.

FDA listed device types

showing 8 of 16

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Adhesive, Bracket And Tooth Conditioner, Resin 1Plate, Fixation, Bone 1Bracket, Ceramic, Orthodontic 1Screw, Fixation, Bone 1Cap, Device Disinfectant 1Washer, Bolt Nut 1Bandage, Cast 1

SP MANUFACTURING PTE LTD

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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