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RICHARD WOLF GMBH

Germany · Knittlingen

✓ 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

168listed device types

Class I 108Class II 60Class III 0

plus 259 registration records and 154 510(k), 4 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

221registered devices

Class I 100Class II 121

272 including historic records

SASaudi ArabiaSFDA

96registered imported devices

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

CACanadaMDALL

21active device licences

Class II 19Class III 2

124 including historic records

TWTaiwanTFDA

51valid device licences

Class I 10Class II 39Class III 2

SGSingaporeHSA SMDR

19device registrations

CLASS B 18CLASS C 1

KRSouth KoreaMFDS GMP

6GMP quality-system certificates

Import 6

AUAustraliaTGA ARTG

98active ARTG entries

Class I 55IIa 28IIb 13Class Is (sterile) 2

HKHong KongMDACS

14valid listings

Class II 9Class III 5

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

9active registrations

Class 2a 6Class 2b 3

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 States259 registration records, 154 510(k), 4 PMA, 10 excluded

Brazil221 confirmed, 2 excluded

Saudi Arabia96 confirmed, 4 excluded

Canada21 confirmed, 2 excluded

Manufacturer names merged into this page: RICHARD WOLF MEDICAL INSTRUMENTS CORP. · RICHARD WOLF GMBH · Richard Wolf · RICHARD WOLF BRASIL EQUIPAMENTOS MEDICINAIS LTDA · Richard Wolf GmbH

FDA 510(k) clearances by year

52000

92001

22002

52003

32004

32005

22007

22008

12009

22012

12013

12016

22017

12018

12019

12020

32021

12022

12023

12024

FDA listed device types

showing 8 of 168

Camera, Still, Endoscopic 1Container, Specimen, Sterile 1Needle, Aspiration And Injection, Disposable 1Stripper, Surgical 1Gag, Mouth 1Set, Laryngeal Injection 1Headlamp, Operating, Battery-Operated 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231291	Perforated Baskets	2024-06-03
US	K230194	HF Surgery Generator 400KHZ	2023-03-22
US	K212808	Logic Hd camera head green, System green	2022-06-14
BR	10317490182	INSTRUMENTAIS ELEMENTOS DE TRABALHO E ADAPTADORES SHARK - RW	Class I
BR	10317490183	INSTRUMENTAIS REPROCESSÁVEIS PRINCESS - RW	Class I
BR	10317490166	INSTRUMENTAIS REPROCESSÁVEIS SHARK - RW	Class I
SA	ME0000001080SFDAA00029	SEALING CAP	—
SA	ME0000001080SFDAA00031	SHEATH TUBE	—
CA	11894	HULKA CLIP	Class III
CA	38097	ARTHROSCOPES	Class II
CA	60176	OESOPHAGOSCOPES	Class II