FDA Registration Active 🇩🇪 Germany

RHENUS SE & CO. KG

Reg #: 3014656749 · FEI: 3014656749 · Expires 2026
Products
45
Proprietary Names
80
Establishment Types
1
Classifications
45

Registration Details

Registration Name
RHENUS SE & CO. KG
Registration Number
3014656749
FEI Number
3014656749
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Rhenus Platz 1
City
Holzwickede North Rhine-Westphalia
Country
DE

Regulatory Submissions

510(k) Number
K161075
PMA Number
P160025

Owner / Operator

Firm Name
Rhenus SE & Co. KG
Operator Number
10057982
Address
Elisabeth-Selbert-Strasse 3
City
Rodgau
State
Hesse
Postal Code
63110
Country
DE
Correspondent
Christopher Hans Essig

US Agent

Business Name
Teleflex Inc.
Contact Name
Divya Raman
Address
3015 Carrington Mill Boulevard
City
Morrisville
State
NC
ZIP
27560
Country
US
Phone
612 4231738

Products

Device Name Product Code
Balloon, Epistaxis EMX
Anesthesia Conduction Kit CAZ
Tube, Tracheal (W/Wo Connector) BTR
Catheter, Retention Type, Balloon EZL
Gag, Mouth KBN
Tube, Bronchial (W/Wo Connector) BTS
Airway, Oropharyngeal, Anesthesiology CAE
Tube Tracheostomy And Tube Cuff JOH
Catheter, Urological KOD
Catheter, Subclavian LFJ
Introducer, Catheter DYB
Dilator, Vessel, For Percutaneous Catheterization DRE
Catheter, Conduction, Anesthetic BSO
Stent, Superficial Femoral Artery NIP
Coronary Covered Stent NIV
Tubes, Gastrointestinal (And Accessories) KNT
Brush, Cleaning, Tracheal Tube EPE
Laryngoscope, Rigid CCW
Set, Tubing And Support, Ventilator (W Harness) BZO
Catheter, Hemodialysis, Non-Implanted MPB
Coronary Drug-Eluting Stent NIQ
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI
Mask, Gas, Anesthetic BSJ
Stent, Iliac NIO
Lubricant, Patient KMJ
Catheter, Angioplasty, Peripheral, Transluminal LIT
Catheter, Percutaneous DQY
Catheter, Intravascular, Diagnostic DQO
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
Electrode, Needle GXZ
Connector, Airway (Extension) BZA
Device, Rebreathing BYW
Stethoscope, Esophageal BZW
Ventilator, Emergency, Manual (Resuscitator) BTM
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Catheter, Rectal GBT
Bag, Intestine KGY
Catheter, Suprapubic (And Accessories) KOB
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
Airway, Nasopharyngeal BTQ
Catheter, Urethral GBM
Wire, Guide, Catheter DQX
Stent, Coronary MAF
Catheter, Flow Directed DYG

Proprietary Names

Inflatable Nasal Tube, Masing pattern; 0.2 Micron In-Line Flat Anesthesia Conduction Filter; Sheridan Endotracheal Tube Rusch Pediatric Silicone Foley; Rusch Silicone Foley; Rusch Silicone Tiemann Foley; RUSCH Brillant Silicone Foley catheter, 100ml; Oberto Mouth prop; PILLING; Mouth Gag; RUSCH Brillant Silicone Foley catheter, 80ml; Rusch Single Lumen Bronchial Tube; LMA Classic; Tracheoflex set short with / without Cuff and Phonation; Tracheoflex set short with / without Cuff; Arrow UltraQuik Tuohy Ultrasound Peripheral Nerve Block Needle; Arrow UltraQuik Ultrasound Peripheral Nerve Block Needle; Nelaton-Robinson catheter, cylindrical; Nelaton-Robinson catheter, Tiemann pattern; Rusch all purpose Robinson / Nelation; Rusch Silicone Coated Foley, and pediatric; Rusch all purpose red rubber; ERU Catheter PVC Tiemann Pattern; Female catheter; Nelaton catheter rubber, cylindrical / Robinson pattern / whistle tip / coaxial / Tiemann pattern; 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter Marked Spring-Wire Guide with Arrow Advancer; 12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set; Standard Connector; Tracheal tube soft rubber; FORTRESS FlexTip Plus Epidural Catheter; Pulsar-18 T3 PAPYRUS Tracheal Tube; RUSCH Miller-Abbott tube; TRACHEAL TUBE; Cleaning Brush; KMEDIC; PILLING; CLEANING; MULTIPLE TRACHEAL T; Rusch MRI; Hudson Anesthesia Circuit Assessories; Corr A Tube; Multiple Ventilator T; Smooth Flo Corr A Tube II; Corr A Flex; Venti RuschFlex, armoured tracheal tube, cuffed; RuschFlex, armoured Tracheal tube; You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter ORSIRO MISSION Rusch EZ-Blocker; 14 Fr Two-Lumen Hemodialysis Catheterization Kit/Set; Anesthesia Face mask, pediatric; Anesthesia Face mask with / without hook ring, black; Facemask Silicone Neck Band; Tracheoflex set short with / without Cuff and Phonation; Tracheoflex set short with / without Cuff; ASTRON Silkospray; Passeo-35 HP Hands-off Thermodilution Catheters MULTIPLE STERILE URETHRAL CATHET; Rusch Intermittent Insertion Kit; Arrow StimuQuik Insulated Peripheral Nerve Block Needle; Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle; CPRAM Respiratory Assist Device; Y Connector Elbow Connector M Connector Connector; Rusch Connector Oxygenator; Rusch Connector with Barbed Elbow; Rusch Connector Trach Tee Fitting; Sher-I-Swiv Double Swivel Connector; Hudson RCI Adaptors and Connectors; Hudson RCI Tubing; Hudson RCI Sensor Tee; Sengstaken Blakemore tube - 4 Lumen, Minnesota Type; Silkobag Rebreathing Bag; REBREATHING; Multiple Rebreathing Bags; Esophageal Stethoscope; REUSABLE BAG MANUAL; Sengstaken Blakemore Tube - 3 Lumen; EquipLED; Rusch LiteSlim; DispoLED; Dolphin; Fiber Optic Laryngoscope Blades and Handles; GreenLED; Standard Laryngoscop Rusch Belly Bag; Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter; Rectal tube, rubber; WECK; MULTIPLE SUPRAPUBIC CA; LMA Fastrach ETT; LMA Unique; LMA Supreme; LMA Fastrach ETT SU; LMA ProSeal; LMA Flexible SU; LMA Fastrach; LMA Classic Excel; LMA Gastro Cuff Pilot; LMA Classic; LMA Flexible; LMA Fastrach ETT; Rusch Rectal Tube rubber, Nordmann patter, cylindrical; LMA Unique Evo; LMA Gastro Cuff Pilot; LMA Flexible PreCurved; LMA Flexible PreCurved Cuff Pilot; MADgic Airway LMA Unique (Silicone Cuff); LMA Unique (Silicone Cuff) Cuff Pilot; LMA Unique PreCurved; LMA Classic; LMA Unique Evo Cuf LMA ProSeal Cuff Deflator; Oropharyngeal Guedel Tube Black; LMA Supreme Plus Pack; LMA Protector Cuff Pilot; LMA Unique (S); LMA Flexible (S); LMA Fastrach Stabiliser Rod; LMA Flexible (S) Cuff Pilot; LMA Unique (S) Cuff Pilot; LMA Protector; LMA Classic Excel; LMA Fastrach; LMA Flexible (SU); LMA ProSeal; LMA Flexible; LMA Supreme; LMA Unique PreCurved Cuff Pilot; LMA ProSeal Introducer; LMA NovaPlus; LMA Fastrach (SU); LMA Cuff-Deflator; LMA Unique; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Passeo-18 Nasopharyngeal tube rubber, Wendl pattern; Catheter Plug, Blunt; Arrow Arterial Catheterization Set; PRO-Kinetic Energy Arrow Thermodilution CathetersInfusion Port Thermodilution Laser Resistant Tube; Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter;

Establishment Types

Export Device to the United States But Perform No Other Operation on Device