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Safe Tech Medical Products, Inc.

USA · Houston

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

8listed device types

Class I 0Class II 7Class III 0unclassified 1

plus 16 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 13

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

pendingnot queried

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 States16 registration records, 2 510(k), 0 PMA, 34 excluded

Brazil13 confirmed, 8 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 5 excluded

Manufacturer names merged into this page: Safe Medical · SAFE MEDICAL LTDA

Same-named companies — This database also contains companies with near-identical names: SAFE MEDICAL LTDA, Safe Medical Design, Safe T Medical Devices, Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11990 · K896722

11991 · K910731

FDA listed device types

Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spondylolisthesis Spinal Fixation 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Appliance, Fixation, Spinal Interlaminal 1Intervertebral Fusion Device With Bone Graft, Cervical 1Orthosis, Spinal Pedicle Fixation 1System, Facet Screw Spinal Device 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K910731	DISPOSABLE RETRACTABLE NEEDLE SYRINGE	1991-05-07
US	K896722	PISTON SYRINGE	1990-01-24
BR	83456870004	KIT CIRURGICO UNIVERSAL SAFE ESTERIL	Class I
BR	83456870001	CAMPO SAFE ESTERIL	Class I
BR	83456870002	KIT SAFE CVC	Class I

Safe Tech Medical Products, 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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