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Safeguard Medical Ltd. SAFEGUARD MEDICAL

USA · Huntersville NC · www.safeguardmedical.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN GB-MF-000012038

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

20UDI-DI device records

Class I 18Class III 2

USUnited StatesFDA openFDA

11listed device types

Class I 10Class II 0Class III 0unclassified 1

plus 11 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

17registered device records

Class I 8Class IIa 1Class IIb 4Class III 1System or Procedure Pack 3

BRBrazilANVISA

16registered devices

Class I 12Class II 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

3valid device licences

Class I 3

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 5IIb 1

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 Union20 raw hits, 0 excluded, 20 confirmed

United States11 registration records, 1 510(k), 0 PMA, 2 excluded

United Kingdom17 confirmed, 0 excluded

Brazil16 confirmed, 2 excluded

Manufacturer names merged into this page: SAFEGUARD MEDICAL TECHNOLOGIES LTD · SAFEGUARD MEDICAL TECHNOLOGIES LTD.

Regulatory identity

EU manufacturer SRN: GB-MF-000012038
EU authorised representative: Safeguard Medical Nordic AB

FDA 510(k) clearances by year

12000 · K993609

FDA listed device types

showing 8 of 11

Stretcher, Hand-Carried 1Belt, Pelvic, Traction 1Needle, Catheter 1Splint, Extremity, Non-Inflatable, External, Non-Sterile 1First Aid Kit Without Drug 1Orthosis, Cervical 1Airway, Nasopharyngeal 1Tourniquet, Nonpneumatic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	05060483570068	—	Class I
EU	05060483571829	—	Class I
EU	05060483571515	—	Class I
EU	05060483571508	—	Class I
UK	67046	Prometheus FullStop	Class I
UK	47694	Burn Jel	Class IIb
UK	46922	ChitoGauze XR PRO	Class III
US	K993609	SOLOGUARD LOCKING PLUS SYRINGE	2000-03-17
BR	80888720029	TALA PÉLVICA PROMETHEUS	Class I
BR	80888720031	TORNIQUETE TMT	Class I
BR	80469670020	Torniquete SWAT-T	Class I

Safeguard Medical Ltd. SAFEGUARD MEDICAL

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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