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RUDOLF RIESTER GMBH & CO. KG.

Germany · Jungingen

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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

32listed device types

Class I 22Class II 10Class III 0

plus 57 registration records and 33 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 5Class II 1

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

SASaudi ArabiaSFDA

19registered imported devices

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

CACanadaMDALL

23active device licences

Class II 23

TWTaiwanTFDA

16valid device licences

Class I 12Class II 4

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 18IIa 1IIb 1Class Im (measuring) 1

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

23active registrations

Class 1 14Class 2a 7Class 2b 2

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 States57 registration records, 33 510(k), 0 PMA, 1 excluded

Brazil6 confirmed, 0 excluded

Saudi Arabia19 confirmed, 0 excluded

Canada23 confirmed, 0 excluded

Manufacturer names merged into this page: RUDOLF RIESTER GMBH · RUDOLF RIESTER GMBH & CO. KG. · RUDOLF RIESTER GMBH & CO. KG

FDA 510(k) clearances by year

121993

51994

61995

51997

22000

22017

12019

FDA listed device types

showing 8 of 32

Speculum, Vaginal, Metal 1Tourniquet, Pneumatic 1Stethoscope, Manual 1Dynamometer, Nonpowered 1Laryngoscope, Rigid 1Laryngoscope, Non-Rigid 1Speculum, Ent 1Mirror, Headband, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K190927	Oscillometric Blood Pressure Monitor	2019-06-24
US	K170538	RVS-100 Vital Signs Monitor	2017-10-17
US	K171182	ri-former Predictive Thermometer	2017-10-04
BR	81346500091	Estetoscópios Riester	Class I
BR	81346500092	Estetoscópios Riester	Class I
BR	81346500093	Estetoscópio Eletrônico ri-sonic®	Class I
SA	ME0000009614SFDAA00001	ri-scope L1 Otoscope head XL 3.5	—
SA	ME0000009614SFDAA00002	ri-scope L1 ophthalmoscope head XL 3.5V	—
CA	82392	EYE TONOMETER SCHIOTZ	Class II
CA	82393	ENT ENDOSCOPE	Class II
CA	82394	LUMBAR PUNCTURE SET	Class II

RUDOLF RIESTER GMBH & CO. KG.

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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