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HENKE-SASS WOLF, GMBH.

Germany · Tuttlingen

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

35listed device types

Class I 14Class II 21Class III 0

plus 73 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

15 including historic records

TWTaiwanTFDA

20valid device licences

Class I 9Class II 11

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

8GMP quality-system certificates

Import 7Manufacturing 1

AUAustraliaTGA ARTG

8active ARTG entries

IIa 5Class Is (sterile) 3

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States73 registration records, 15 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: HENKE SASS WOLF OF AMERICA, INC. · HENKE-SASS WOLF, GMBH. · HENKE-SASS WOLF GMBH · HENKE-SASS, WOLF GMBH · HENKE SASS WOLF GMBH · Henke-Sass, Wolf Gmbh

FDA 510(k) clearances by year

31994

11996

11997

21998

11999

12002

12003

12005

12008

12010

12017

12018

FDA listed device types

showing 8 of 35

Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Lithotriptor, Biliary Mechanical 1Laparoscope, Gynecologic (And Accessories) 1Needle, Hypodermic, Single Lumen 1Laparoscope, General & Plastic Surgery 1Resectoscope, Working Element 1Nasopharyngoscope (Flexible Or Rigid) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173070	HSW Resection Instruments	2018-06-08
US	K171336	Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath	2017-12-07
US	K101547	HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)	2010-11-22
BR	80533420076	INSTRUMENTAL CIRÚRGICO PARA ENDOSCOPIA RÍGIDA ENDOMASTER	Class II
BR	10349009016	Endoscópio rígido UHD 4K	Class II
BR	80912390006	INSTRUMENTAL CIRÚRGICO PARA ENDOSCOPIA NÃO ARTICULADO NÃO CORTANTE	Class II
SA	ME0000001858SFDAA00002	Obturator conical blunt for 6mm trocar sheath	—
CA	98510	FLEXIBLE NASOLARYNGOSCOPE	Class II
CA	102921	HSW DENTAL INTRALIGAMENTARY SYRINGES AND DENTAL CARTRIDGE SYRINGES	Class II