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Thermo Fisher Scientific (Nalge Nunc Intl)

USA · Rochester

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Israel — 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

6listed device types

Class I 5Class II 1Class III 0

plus 6 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

3registrations

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, 1 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: Nalge Nunc International Corporation · NALGE NUNC INTERNATIONAL CORPORATION

FDA 510(k) clearances by year

12009 · K090429

FDA listed device types

Labware, Assisted Reproduction, Exempt 1Container, Specimen, Sterile 1Container, Specimen, Non-Sterile 1Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile 1Micro Pipette 1Device, Gas Generating 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K090429	NUNC IVF CENTERWELL AND ICSI DISHES	2009-09-18
BR	10358940102	Família Thermo Scientific Linear Barcoded Tubes	Class I
BR	10358940100	Família Nunc Cryobank Vial Systems	Class I
BR	10358940101	Família NalgeneTM Cryogenic Tubes	Class I

Thermo Fisher Scientific (Nalge Nunc Intl)

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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