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KRONNER PROTOTYPES, INC.

USA · Roseburg

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

5listed device types

Class I 3Class II 2Class III 0

plus 5 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

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 States5 registration records, 4 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: KRONNER PROTOTYPES, INC.

FDA 510(k) clearances by year

11994 · K941348

11998 · K973543

12000 · K000663

12013 · K130758

FDA listed device types

Cannula, Manipulator/Injector, Uterine 1Laparoscope, General & Plastic Surgery 1Instrument, Cast Application/Removal, Manual 1Retractor, Vaginal 1Retractor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K130758	KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER	2013-12-11
US	K000663	KRONNER LOW PROFILE SCOPE HOLDER	2000-05-02
US	K973543	KRONNER LOW PROFILE SCOPE HOLDER	1998-01-12

KRONNER PROTOTYPES, 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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