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Phoenix Healthcare Solutions, LLC

USA · Fort Lauderdale FL · www.phoenixhealthcaresolutions.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN IT-MF-000023426

This company has registrations in European Union, United Kingdom, Brazil, Australia — 4 overseas markets. EU UDI-DI records ≥265, the first 300 verified individually. 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

≥265UDI-DI device records

Class IIa 265

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 2

BRBrazilANVISA

1registered devices

Class II 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

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 Union2,185 raw hits, 35 excluded, 265 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 42 excluded

United Kingdom2 confirmed, 9 excluded

Brazil1 confirmed, 6 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: PHOENIX HEALTHCARE SOLUTIONS, LLC.

Regulatory identity

EU manufacturer SRN: IT-MF-000023426
UK responsible person: Arcomedical Infusion Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08052747956555	Set d'aspirazione	Class IIa
EU	08052747956692	Extension Line	Class IIa
EU	08052747956401	Set d'aspirazione	Class IIa
EU	08052747955466	Infuset	Class IIa
UK	58977	Volumed Burette Set	Class IIa
UK	12170	PCA Syramed Extension	Class IIa
BR	80686360219	BULLSEYE SAFETY LANCET	Class II

Phoenix Healthcare Solutions, LLC

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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