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KOLPLAST C I LTDA

Brazil · Itupeva Sao Paulo

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

10listed device types

Class I 7Class II 3Class III 0

plus 12 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

192registered devices

Class I 160Class II 32

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

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 States12 registration records, 2 510(k), 0 PMA, 1 excluded

Brazil192 confirmed, 0 excluded

Manufacturer names merged into this page: Kolplast Ci Ltda · KOLPLAST CI LTDA · KOLPLAST C I LTDA

FDA 510(k) clearances by year

12011 · K110766

12017 · K153128

FDA listed device types

showing 8 of 10

Lamp, Surgical 1Spatula, Cervical, Cytological 1Speculum, Vaginal, Nonmetal 1Preservative, Cytological 1Cytocentrifuge 1Speculum, Rectal 1Slides, Microscope 1Filters, Cell Collection, Tissue Processing 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K153128	Kolplast Cervical Sample Collection Kit	2017-01-13
US	K110766	KOLPLUX SYSTEM	2011-09-15
BR	10237610011	KIT PAPANICOLAU KOLPLAST	Class I
BR	10237610008	PINCA POZZY DESCARTAVEL KOLPLAST	Class I
BR	10237610007	Kit Retirada de Pontos 1	Class II

KOLPLAST C I LTDA

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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