Home›Brazil›TIMPEL S.A.

TIMPEL S.A.

Brazil · Sao Paulo

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Hong Kong, Israel — 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

2listed device types

Class I 0Class II 2Class III 0

plus 6 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 6Class II 7

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 3IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

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, 3 510(k), 0 PMA, 1 excluded

Brazil13 confirmed, 0 excluded

Manufacturer names merged into this page: TIMPEL S.A. · Timpel S.A.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250464	Enlight 2100 (TPL-E2103-0)	2025-09-10
US	K222897	Enlight 2100	2023-03-07
US	K211135	Enlight 2100	2022-01-06
BR	81408220006	Addere	Class I
BR	81408229008	EIT Module	Class II
BR	81408229006	Nep	Class II

TIMPEL S.A.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies