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Plum Safety ApS

Denmark · Assens · www.plum.eu

✓ Record-verifiedregistrations found in 6 marketsEU SRN DK-MF-000008672

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

20UDI-DI device records

Class I 20

USUnited StatesFDA openFDA

1listed device types

Class I 1Class II 0Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 3Class IIb 4

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

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 2IIb 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 2

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 Union20 raw hits, 0 excluded, 20 confirmed

United States1 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom7 confirmed, 1 excluded

Manufacturer names merged into this page: PLUM Safety ApS

Regulatory identity

EU manufacturer SRN: DK-MF-000008672
UK responsible person: Topdental (Products) Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05715205001350	Plum QuickFix Water Protect	Class I
EU	05715205700093	Plum QuickFix Textile	Class I
EU	05715205001589	Plum QuickFix To Go Elastic	Class I
EU	05715205000469	Plum QuickFix XRay Long	Class I
UK	11655	Plum Eyewash	Class I
UK	11655	Plum Wound and Eyewash 0.9% Sodium Chloride	Class IIb
UK	11655	Plum Wound and Eyewash pH Neutral 4.9% Phosphate	Class IIb

Plum Safety ApS

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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