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SAFETEC OF AMERICA, INC.

USA · Buffalo

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 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

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 5Class II 1Class III 0

plus 6 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

1active ARTG entries

Class I 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.

United States6 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: SAFETEC OF AMERICA, INC.

FDA 510(k) clearances by year

11995 · K952962

31996 · K960073

FDA listed device types

Urinary Drainage Collection Kit, For Indwelling Catheter 1Accessories, Cleaning Brushes, For Endoscope 1Scissors, Medical, Disposable 1Solvent, Adhesive Tape 1Brush, Cleaning, Tracheal Tube 1Catheter, Rectal For Continent Ileostomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K960073	EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP	1996-07-12
US	K960048	EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS	1996-07-12
US	K953461	CPR MASK & RELATED FAMILY KITS	1996-01-04

SAFETEC OF AMERICA, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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