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Hennig Enterprises Europe Srl

Australia · Perth

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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 1Class II 7Class III 0

plus 8 registration records and 3 510(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

1active device licences

Class II 1

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 States8 registration records, 3 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: HENNIG ENTERPRISES EUROPE S.R.L. · SC HENNIG ENTERPRISES EUROPE SRL

Same-named companies — This database also contains companies with near-identical names: HENNIG ENTERPRISES EUROPE S.R.L., Sc Hennig Enterprises Europe Srl. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11999 · K993651

22003 · K020424

FDA listed device types

Amniotome 1Pump, Infusion, Elastomeric 1Pump, Infusion 1Catheter, Urological 1Set, Administration, Intravascular 1Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) 1Accessories, Catheter, G-U 1Catheter, Urethral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K020424	V SET	2003-08-29
US	K020421	GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES	2003-04-29
US	K993651	O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER	1999-12-23
CA	78458	O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER	Class II

Hennig Enterprises Europe Srl

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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