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Sage Products, Inc.

USA · Cary

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Singapore, Israel, Russia — 6 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

14listed device types

Class I 13Class II 1Class III 0

plus 14 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 7Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

11registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States14 registration records, 32 510(k), 0 PMA, 6 excluded

Brazil8 confirmed, 1 excluded

Saudi Arabia11 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SAGE PRODUCTS LLC · SAGE PRODUCTS LLC/COMFORT PERSONAL CLEANSING PRODUCTS · Sage Products Inc. · Sage Products LLC (Comfort Personal Cleansing Products)

FDA 510(k) clearances by year

11978

11979

41980

51982

11983

21987

11989

11990

21994

31995

41996

51997

21998

FDA listed device types

showing 8 of 14

Protector, Skin Pressure 1Patient Personal Hygiene Kit 1Decontamination Kit 1Support, Patient Position 1Collector, Urine, Powered, Non Indwelling Catheter 1Mattress, Flotation Therapy, Non-Powered 1Applicator, Absorbent Tipped, Non-Sterile 1Toothbrush, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K972705	RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC	1998-04-30
US	K980490	SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS	1998-02-24
US	K973911	2 GALLON ALTERNATE CARE SHARPS CONTAINER	1997-10-29
BR	10178010144	KIT DE ASPIRACAO E LIMPEZA ORAL Q-CARE (Q8º)	Class I
BR	10178010235	Bota Protetora Prevalon	Class I
BR	10178010237	SISTEMA DE POSICIONAMENTO PREVALON PADRÃO	Class I
SA	ME0000005960SFDAA00003	Sage Oral Swab with Corinz™ Oral Rinse	—
SA	ME0000005960SFDAA00007	Sage PrimoFit	—

Sage 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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