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Firefly Global

USA · Belmont MA · www.fireflyglobal.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN US-MF-000020015

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel — 7 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

21UDI-DI device records

Class I 21

USUnited StatesFDA openFDA

7listed device types

Class I 6Class II 1Class III 0

plus 7 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 5

BRBrazilANVISA

1registered devices

Class I 1

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

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union22 raw hits, 1 excluded, 21 confirmed

United States7 registration records, 0 510(k), 0 PMA, 4 excluded

United Kingdom5 confirmed, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: FIREFLY GLOBAL

Regulatory identity

EU manufacturer SRN: US-MF-000020015
EU authorised representative: MDSS GmbH
UK responsible person: MDSS-UK RP LIMITED

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00851289007385	—	Class I
EU	00851289007361	—	Class I
EU	00851289007347	—	Class I
EU	00851289007323	—	Class I
UK	47160	Digital Dermatoscope	Class I
UK	35958	Digital Camera	Class I
UK	35906	Compact Light Source	Class I
BR	80827000014	Tricoscópio Digital Firefly	Class I

Firefly Global

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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