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Data / Medical devices / Germany / Rudolf Riester GMBH

Rudolf Riester GMBH: FDA-registered device maker in JUNGINGEN Baden-Wurttemberg, Germany, 31 510(k) clearances

Rudolf Riester GMBH is registered with the FDA (registration 8010482) in JUNGINGEN Baden-Wurttemberg, Germany. It lists 31 device types. The FDA files 31 510(k) clearances under its listings, the newest dated June 24, 2019. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Rudolf Riester GMBH
FDA registration number
8010482
FEI number
1000292048
Address
Bruckstrasse 31, JUNGINGEN Baden-Wurttemberg, Germany, D-72417
Owner or operator
RUDOLF RIESTER GMBH & CO. KG (8010492)
Roles
Manufacturer, Repackager or relabeler
First device listed
November 17, 1978
Registered through
2026
Brand names listed
Dermatoscope lens for RCS-100, ENT, EliteVue, FORK, TUNING, FORTELUX N, Fortelux H, General lens RCS-100, K-L.E.D Surgical Headlight and more

Devices it lists

DeviceProduct codeClassRoleSource
Blood Pressure CuffDXQ2Manufactureraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Repackager or relabeleraccessdata.fda.gov
Camera, Still, SurgicalFTT1Manufactureraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Medical Examination, Ac PoweredKZF1Manufactureraccessdata.fda.gov
Dynamometer, NonpoweredHRW1Manufactureraccessdata.fda.gov
Fork, TuningGWX1Manufactureraccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Manufactureraccessdata.fda.gov
Laryngoscope, Non-RigidCAL1Manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Light, Examination, Medical, Battery PoweredKYT1Manufactureraccessdata.fda.gov
Light, Surgical HeadlightEBA1Repackager or relabeleraccessdata.fda.gov
Loupe, Binocular, Low PowerHJH1Repackager or relabeleraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Manufactureraccessdata.fda.gov
Mirror, Headband, OphthalmicHKF1Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Manufactureraccessdata.fda.gov
Ophthalmoscope, Battery-PoweredHLJ2Manufactureraccessdata.fda.gov
OtoscopeERA1Manufactureraccessdata.fda.gov
OximeterDQA2Repackager or relabeleraccessdata.fda.gov
PercussorGWZ1Manufactureraccessdata.fda.gov
Retinoscope, Battery-PoweredHKM1Manufactureraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Speculum, IlluminatedFXF1Manufactureraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Manufactureraccessdata.fda.gov
Stethoscope, ElectronicDQD2Manufactureraccessdata.fda.gov
Stethoscope, ManualLDE1Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tonometer, ManualHKY2Manufactureraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufactureraccessdata.fda.gov
Tourniquet, PneumaticKCY1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 24, 2019K190927Oscillometric Blood Pressure MonitorDXNSubstantially EquivalentRudolf Riester GmbHaccessdata.fda.gov
October 17, 2017K170538RVS-100 Vital Signs MonitorMWISubstantially EquivalentRudolf Riester GmbHaccessdata.fda.gov
October 11, 2013K132560PCP-USB STETHOSCOPEDQDSubstantially EquivalentRnk Products, Inc.accessdata.fda.gov
October 11, 2013K132405PPA/BT-RB STETHOSCOPEDQDSubstantially EquivalentRnk Products, Inc.accessdata.fda.gov
September 28, 2012K120982DIGITAL EYE-FUNDUS CAMERAHKISubstantially EquivalentMedimaging Integrated Solutions, Inc. (Miis)accessdata.fda.gov
January 20, 2011K102893PCP/PC STETHOSCOPEDQDSubstantially EquivalentRnk Products, Inc.accessdata.fda.gov
August 13, 2007K070371FINGERTIP PULSE OXIMETER MD300CDQASubstantially EquivalentBeijing Choice Electronic Technololgy Co., Ltd.accessdata.fda.gov
May 2, 2007K070750247 BP DEVICEDXNSubstantially EquivalentSuntech Medical, Inc.accessdata.fda.gov
January 17, 2002K013485MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1DXNSubstantially EquivalentMicrolife Corp.accessdata.fda.gov
December 21, 2000K002954RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERSDXQSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
October 25, 2000K003004OSCAR 2, MODEL 222DXNSubstantially EquivalentSuntech Medical Instruments, Inc.accessdata.fda.gov
September 24, 1997K972379PRECISA NDXQSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
September 17, 1997K972301BIG BEN SQUARE, BIG BEN ROUNDDXQSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
January 9, 1997K964338RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOTHKMSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
July 24, 1995K950914RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/VHLJSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
May 12, 1995K950913PERFECT, ENT SET, PRAKTIKANT, DE LUXEERASubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
May 8, 1995K945541SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALEHKYSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
March 20, 1995K945425MCINTOSH, MILLER, FOREGGER BABYCCWSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
December 9, 1994K945507H 5100, H 5200, H 5300KZFSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
November 30, 1994K944337VARIOUS STETHOSCOPESLDESubstantially EquivalentRud Riester GmbH & CO KGaccessdata.fda.gov
November 29, 1994K942649MINIMUS I; MINIMUS III, SANAPHONDXNSubstantially EquivalentRud Riester GmbH & CO KGaccessdata.fda.gov
July 27, 1994K943461VARIOUS TYPES OF MERCURIALSDXNSubstantially EquivalentRud Riester GmbH & CO KGaccessdata.fda.gov
July 27, 1994K942777MINIMUS II; MINIMUS II COLOR; BABYPHONDXQSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
March 25, 1994K925295EXACTA-SPEZIALDXNSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
October 18, 1993K925756UNI IIHLJSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
October 8, 1993K932506RI-SCOPE (S)ERASubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
October 8, 1993K932503RI-MINIERASubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
October 8, 1993K925754ECONOMEPYSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
October 8, 1993K925753UNI IIIERASubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
August 3, 1993K925757OPHTHALMOSCOPEHLJSubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov
July 26, 1993K925759UNI IERASubstantially EquivalentRudolf Riester GmbH & Co. KGaccessdata.fda.gov

Compare with other makers

Updated June 24, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.