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KATENA PRODUCTS, INC.

USA · Parsippany

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel — 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

pendingnot queried

USUnited StatesFDA openFDA

70listed device types

Class I 59Class II 9Class III 0unclassified 2

plus 173 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 5Class II 3

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

SASaudi ArabiaSFDA

44registered imported devices

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

CACanadaMDALL

10active device licences

Class II 9Class III 1

51 including historic records

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

48active ARTG entries

Class I 38IIa 2IIb 1Class Is (sterile) 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

9registrations

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 States173 registration records, 3 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Saudi Arabia44 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: KATENA PRODUCTS, INC. · KATENA PRODUCTS INC. · KATENA PRODUCTS INC

FDA 510(k) clearances by year

11978 · K781866

11990 · K897034

11992 · K912576

FDA listed device types

showing 8 of 70

Strip, Schirmer 1Chisel, Surgical, Manual 1Hook, Ophthalmic 1Marker, Ocular 1Handle, Scalpel 1Blade, Scalpel 1Needle, Aspiration And Injection, Disposable 1Clamp, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K912576	INSTRUMENT WIPE AND CORNEAL SHIELD	1992-01-31
US	K897034	K-SPONGE	1990-02-15
US	K781866	CANNULA CADDY	1978-11-15
BR	80170280002	KATENA TREPHINE BLADE	Class II
BR	80420200010	INSTRUMENTAL ARTICULADO NÃO CORTANTE KATENA	Class I
BR	80420200011	INSTRUMENTAL ARTICULADO PERFUROCORTANTE KATENA	Class I
SA	ME0000004799SFDAA00005	SPECULMS	—
SA	ME0000004799SFDAA00008	Fixation Rings	—
CA	72186	VITREOUS SCISSORS WITH IRRIGATION	Class II
CA	93234	OPHTHALMIC HOOKS	Class II
CA	93297	CONFORMER	Class II

KATENA 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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