Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010482

FEI Number

1000292048

Entity Name

RUDOLF RIESTER GMBH

City/State/Country

JUNGINGEN Baden-Wurttemberg, DE

Establishment Address

BRUCKSTRASSE 31, JUNGINGEN Baden-Wurttemberg D-72417, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RUDOLF RIESTER GMBH & CO. KG (Owner Number: 8010492)

Owner / Operator Contact Address

BRUCKSTRASSE 31, P.O. BOX 35, JUNGINGEN, DE-NOTA D-72417, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ri-san ri-fox N ri-sonic PCP-1 global diplomat pen-scope ri-mini e-scope uni I ri-sonic PCP-USB ri-magic ri-magic LED uni III RCS-100 camera system PPA/BT-RB pinard graeve speculight cusco RBP-100 Otoscopic lens for ri-screen RVS-200 ri-scope® otoscope RVS-200 ri-scope® human operation otoscope without speculum RVS-200 ri-scope® F.O. bent arm illuminator RVS-200 ri-scope® F.O. tongue blade holder RVS-200 ri-scope® nasal speculum Otoscope lens for RCS-100 OTOSCOPE RI-CLIP ri-thermo N ri-integral flex schiötz ri-former Predective Thermometer RPT-100 uni II ri-medic dynatest, Dynamometer ri-modul ri-integral ri-standard ri-dispo XL100 XL150 XL24 ri-cardio EliteVue ri-scope L ri-thermo® sensioPRO ri-thermo® sensioPRO+ ri-thermo® tymPRO ri-thermo® tymPRO+ ziegler ri-clar clar N General lens RCS-100 LARYNGOSCOPE, RIGID ri-thermo®tymPRO+ with Smart Cradle econom ri-gital minimus II babyphon ri-champion N K-L.E.D Surgical Headlight big ben round/square metpak RVS-200 ri-scope® L ophthalmoscope Retinal ophthalmic lens 40° Retinal ophthalmic lens 25° ri-former Dermatoscope lens for RCS-100 ri-derma Dermatoscope RVS-200 ri-scope® dermatoscope e-xam ri-special Fortelux H ri-focus ri-pen RI-LIGHT FORTELUX N cardiophon 2 duplex 2 tristar ri-rap anestophon duplex cardiophon RVS-100 Vital Signs Monitor komprimeter SuperVu Series SuperVu Hi-Res Series SuperVu XL Series RVS-200 ri-scope® retinoscope (skiascope)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	1978-11-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-12-16
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2021-05-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2009-04-30
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2009-04-30
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2009-04-30
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2009-04-30
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2021-05-21
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2009-04-30
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2009-04-30
FTT	Camera, Still, Surgical	General, Plastic Surgery	Class 1	878.4160	2014-03-20
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2021-05-28
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	1978-12-21
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1978-12-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-07-05
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	1978-12-21
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2006-04-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-06-11
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2006-05-25
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2009-02-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-10-16
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2009-04-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-08-28
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	2009-05-07
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2009-04-30
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2009-05-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-11-12
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2009-04-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-03-27
HKF	Mirror, Headband, Ophthalmic	Ophthalmic	Class 1	886.1500	1981-07-21
FXF	Speculum, Illuminated	General, Plastic Surgery	Class 1	878.1800	2014-03-20
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2006-05-25
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-12-04
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2009-04-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2008-06-11
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2009-04-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2008-08-29
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2010-04-13
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2009-04-30
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2006-04-07
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2017-10-25
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	Class 2	886.1120	2014-03-20
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2009-04-30
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2009-04-30
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2009-05-07
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2006-04-07
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2009-04-30
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-10-18
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2009-05-07
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2010-04-13
HKM	Retinoscope, Battery-Powered	Ophthalmic	Class 1	886.1780	2017-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

RUDOLF RIESTER GMBH & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010482. Last updated year: 2026. Please use registration number 8010482 when referencing this establishment in official correspondence.