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Island Polymer Industries GmbH

Germany · Bitterfeld-Wolfen · www.islandpolymer.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN DE-MF-000011884

This company has registrations in European Union, United States, United Kingdom — 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

4UDI-DI device records

IVD A 4

USUnited StatesFDA openFDA

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

IVD A 1

BRBrazilANVISA

0registered devices

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.

European Union32 raw hits, 28 excluded, 4 confirmed

United States2 registration records, 0 510(k), 0 PMA, 16 excluded

United Kingdom1 confirmed, 3 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ISLAND POLYMER INDUSTRIES-GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000011884
UK responsible person: CellPath Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04260606591029	IPI Pathoslide® 2.0	IVD A
EU	04260606592019	IPI Pathomat®	IVD A
EU	04260606591012	IPI Pathoslide	IVD A
EU	04260606590015	IPI Pathotape	IVD A
UK	15687	Microscope slide coverslip IVD	IVD A

Island Polymer Industries GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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