FDA Registration
Active
🇩🇪 Germany
RUDOLF RIESTER GMBH
Reg #: 8010482
·
FEI: 1000292048
·
Expires 2026
Products
32
Proprietary Names
111
Establishment Types
2
Classifications
32
Registration Details
- Registration Name
- RUDOLF RIESTER GMBH
- Registration Number
- 8010482
- FEI Number
- 1000292048
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BRUCKSTRASSE 31
- City
- JUNGINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K002954
Owner / Operator
- Firm Name
- RUDOLF RIESTER GMBH & CO. KG
- Operator Number
- 8010492
- Address
- BRUCKSTRASSE 31, P.O. BOX 35
- City
- JUNGINGEN
- State
- DE-NOTA
- Postal Code
- D-72417
- Country
- DE
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 1978-11-17 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2010-12-16 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2021-05-21 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2009-04-30 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2009-04-30 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2009-04-30 |
| Camera, Still, Surgical | FTT | Class 1 | General, Plastic Surgery | No | 2014-03-20 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 1978-12-21 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 1978-12-21 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2006-04-07 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2008-06-11 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2006-05-25 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2009-02-26 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2009-04-30 |
| Dynamometer, Nonpowered | HRW | Class 1 | Orthopedic | No | 2009-05-07 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2009-04-30 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2009-05-07 |
| Mirror, Headband, Ophthalmic | HKF | Class 1 | Ophthalmic | No | 1981-07-21 |
| Speculum, Illuminated | FXF | Class 1 | General, Plastic Surgery | No | 2014-03-20 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-12-04 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2009-04-30 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2010-04-13 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2006-04-07 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2014-03-20 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2009-05-07 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2006-04-07 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2017-10-18 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2009-05-07 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2010-04-13 |
| Retinoscope, Battery-Powered | HKM | Class 1 | Ophthalmic | No | 2017-10-25 |
| Percussor | GWZ | Class 1 | Neurology | No | 1978-12-21 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2006-04-07 |
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)
buck
berliner
queens
taylor
troemner
babinsky
dejerine
ri-vision Retinoscope
ri-scope Retinoscope
de luxe
ri-charger
ENT
praktikant
perfect
ri-charger L
sphygmotensiophon
sanaphon
minimus III
FORK, TUNING
exacta
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device