FDA Registration Active 🇩🇪 Germany

Arvato SE

Reg #: 3013247477 · FEI: 3013247477 · Expires 2026
Products
95
Proprietary Names
276
Establishment Types
1
Classifications
95

Registration Details

Registration Name
Arvato SE
Registration Number
3013247477
FEI Number
3013247477
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Werner-Schroeder Str 1
City
Hamburg
Country
DE

Regulatory Submissions

510(k) Number
K942839

Owner / Operator

Firm Name
Arvato SE
Operator Number
10053073
Address
Werner-Schroeder Str 1
City
Hamburg
State
DE-HH
Postal Code
21035
Country
DE
Correspondent
Carsten Thiemt

US Agent

Business Name
Gyrus ACMI, Inc.
Contact Name
Todd Brill
Address
800 West Park Drive, --
City
Westborough
State
MA
ZIP
01581
Country
US
Phone
508 2077661

Products

Device Name Product Code
Knife, Ent KTG
Surgical Instruments, G-U, Manual (And Accessories) KOA
Hook, Microsurgical Ear JYL
Laparoscope, General & Plastic Surgery GCJ
Electrosurgical, Cutting & Coagulation & Accessories GEI
Arthroscope HRX
Hysteroscope (And Accessories) HIH
Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
Tray, Surgical, Ent MMO
Laparoscope, Gynecologic (And Accessories) HET
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Cannula, Surgical, General & Plastic Surgery GEA
Ureteroscope And Accessories, Flexible/Rigid FGB
Laryngostroboscope EQL
Catheter And Tip, Suction JOL
Accessories, Cleaning Brushes, For Endoscope MNL
Mediastinoscope, Surgical EWY
Electrode, Electrosurgical, Active, Urological FAS
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Withdrawal/Infusion Pump DQI
Trocar, Ent KTE
Mallet HXL
Spatula, Surgical, General & Plastic Surgery GAF
Source, Carrier, Fiberoptic Light EQH
Tray, Surgical, Instrument FSM
Curette, Nasal KAP
Fork, Tuning GWX
Probe, Ent KAK
Nasopharyngoscope (Flexible Or Rigid) EOB
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
Resectoscope, Working Element FDC
Choledochoscope And Accessories, Flexible/Rigid FBN
Resectoscope FJL
Gastroscope And Accessories, Flexible/Rigid FDS
Light Source, Fiberoptic, Routine FCW
Led Light Source NTN
Elevator, Ent KAD
Retractor, Ent KAL
Saw, Nasal KBC
Rasp HTR
Pump, Air, Non-Manual, For Endoscope FEQ
Syringe, Irrigating (Non Dental) KYZ
Forceps, Ent KAE
Apparatus, Exhaust, Surgical FYD
Kit, Nephroscope FGA
Laparoscope And Accessories, Gynecologic, Reprocessed NMH
Gauge, Measuring JYJ
Chisel, Surgical, Manual FZO
Dilator, Tracheal KCG
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
Punch, Ent KTF
Speculum, Ent EPY
Electrode, Electrosurgical JOS
Hysteroscope Accessories NWW
Transilluminator, Fiber Optic MQW
Instrument, Ent Manual Surgical LRC
Light, Surgical Headlight EBA
Instrument, Ligature Passing And Knot Tying HCF
Illuminator, Fiberoptic, Surgical Field HBI
Endoscope, Accessories, Narrow Band Spectrum NWB
Endoscope, Ac-Powered And Accessories GCP
Cystoscope And Accessories, Flexible/Rigid FAJ
Urethrotome EZO
Tray, Surgical LRP
Block, Cutting, Ent, Non-Sterile NNR
Dissector, Tonsil KBM
Perforator, Ear-Lobe JYS
Coagulator, Culdoscopic (And Accessories) HFI
Insufflator, Hysteroscopic HIG
Mirror, Headband, Ophthalmic HKF
Forceps HTD
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Confocal Optical Imaging OWN
Bur, Ear, Nose And Throat EQJ
Rongeur, Nasal KBB
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Mirror, Ent KAI
Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
Urethroscope FGC
Telescope, Rigid, Endoscopic FBP
Scissors, General, Surgical LRW
Endoscope, Rigid GCM
Laryngoscope, Rigid CCW
Inserter, Myringotomy Tube JYM
Display, Cathode-Ray Tube, Medical DXJ
Knife, Ear JYO
Instrument, Ultrasonic Surgical LFL
Forceps, Biopsy, Electric KGE
System, Digital Image Communications, Radiological LMD
Tube, Smoke Removal, Endoscopic FCZ
Catheter, Suprapubic (And Accessories) KOB
Cystourethroscope FBO
Endoscope, Neurological GWG
Stents, Drains And Dilators For The Biliary Ducts FGE
Endoscopic Access Overtube, Gastroenterology-Urology FED

Proprietary Names

Knife Scalpel handle Ear knife Incision knife Round knife Adenotome Roller knife Tonsil knife Swivel knife Dissector Lancet knife Laryngeal knife Sickle knife Scissors Biopsy forceps Grasping forceps Hook Knot pusher Needle Introducer Pick Tracheal hook Ear hook Superview Laparoscope System for General Surgery MAPC Probes ONE PIECE SIDE EFFECT ELECTRODE CoolPulse 90 Electrode with Hand Controls MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE Disposable Lap. Instruments HF Resection Electrode Loop with Runner GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE) Jar, stainless steel Glass tray LAPAROSCOPIC SCISSORS INNER SHEATH (RESECTOSCOPE SHEATH, INNER - 24 Fr. Electrosurgical Generator ESG-410 and Accessories Roller Electrodes for OB/Gyn HI-Q HAND INSTRUMENTS, OB/GYN USE OLYMPUS BIPOLAR FORCEPS AND ACCESSORIES PK Superpulse System Generator Model 744000 HF-cables (reusable) Suction tube Septum cannula Cannula Mandrin, for Suction tubes Ureteroscopes, flexible and rigid, light source, video processor LARYNGOSTROBOSCOPE LIGHT SOURCE FOR STROBOSCOPY Septum needle Bipolar Applicator CELON ProCurve V Cleaning Accessory Electrode, Fine Needle Gyrus G3 Generator Mediastinoscope Hysteroscopes, forceps VAPR COOLPULSE Curve Suction Electrode PK Button OLYMPUS STERILIZATION TRAYS Olympus KeyMed Instrument Tray Tube set Flexible Tipe Thoraroscope Trocar Mallet WB990310; WB990311; WB990210;WB990211 Teeth protector Spatula Tongue depressor Light carrier, fiber optic Throat microphone Light source Tray HF Resection Electrodes Loop Ear loop Ear curette Polyp snare Noise apparatus Tuning fork Rule Probe Measuring instrument Plastic Surgery System Instrument tray, for semi-rigid ureteroscope Resection Sheath for Hysteroscopy Instrument basket, for EndoEYE Sinuscope VAPR TC ELECTRODE GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE) GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE Suction Coagulator PK PLASMA-V INSTRUMENT Choledochoscope, flexible and rigid Gyrus Plasma Sect Urology Telescope "V-DOV" Gyrus Plasma V; Gyrus Urology Kit; Plasma Cise; Plasma Cut CLL-V1 LED Light Source Elevator Suction elevator Retractor and accessories Semi-rigid scissors Saw Raspatory Scoring instrument Cartilage crusher Rasp Resection Sheath for Urology ESG-100 AFU-100 HYSTEROSCOPIC BRIDGE (VISUAL OBTURATOR) ROTATABLE OUTER SHEATH Electrosurgical Generator ESG-150 Syringe Micro-biopsy forceps Artery forceps Dissection forceps Tonsil forceps VICROSAFE 6 AND VICROSAFE 12 Rigid and percutaneous nephroscope Disposable Electrosurgical Pencil Ultra telescopes VAPR ARCTIC articulating hip electrode with dome tip Gauge pin Osteotome Gouge Chisel Dilator Versapoint Punch forceps Speculum and accessories PK Generator; PlasmaKinetic System HF-resection electrodes Hysteroscope accessories Light carrier Light clip OLYMPUS RIGID URETERORENOSCOPE Electrosurgical loops Articulated arm and accessories Chest support PENADAPT 10 Head light RD SHORT WEDGE (2.3mm WEDGE (SHORT)) RD STANDARD WEDGE 2.3mm WEDGE Needle, for fascial closure Cogent 1 Cord; Gyrus PK Footswitch Light-guide cable MINI LAPAROSCOPY FOR GENERAL SURGERY ENDOEYE HD II Trocar System; Hasson OES ELITE Cystoscope and Accessories Flexible and rigid ureterotome system PKS BiLL HF Resection electrode, cylinder HF Resection Electrode Loop with runner Kidney bowl Round bowl Medicine cup Rack PK Lap Loop Cutting block Cutting jig OLYMPUS OES LAPAROSCOPY SYSTEM HYF Hysteroscopes and telescopes Tonsil dissector and retractor Cysto-urethroscopes and forceps Hand perforator Perforator Tonsil needle Thorascoscope system Arthroscopes, CLV-S20 light source PK Cord; PK generator; SuperLoop; SuperPulse generator; SuperSect Disposable Bipolar Forceps Cable G400 Workstation HYSTEROSCOPY PUMP Monopolar single-use HF cable Head band Clip applier Laryngeal forceps Thumb forceps Swab forceps Gelfoam pressure forceps Adenoid forceps Nasal forceps Turbinate forceps Septum forceps Needle holder Towel forceps Pharyngeal forceps Cotton applicator Ear forceps Dressing forceps Electrode, Blade PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM OES Elite Ureteroscopes and Accessories RD END ELECTRODE (2.3 VAPR END EFFECT) Neutral electrode cable SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND Steritray XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT RD SIDE ELECTRODE (2.3 VAPR SIDE EFFECT) Telescope "IR" Telescope "ULTRA" EndoLED Light Source Dermabrader Burr Bone rongeur Leakage Tester Adapter Cleaning Accessories Light-guide Adapter Hi-Q Instruments Bipolar Grasping Forceps BiQ+ Mirror Head mirror CoolPulse 90 Electrode without Hand Controls Tubing Optical Obturator Plastic Surgery System hand instruments ONE PIECE LOW PROFILE SUCTION (LPS) ELECTRODE ONE PIECE S50 PLUS ELECTRODE VISICLEAR SMOKE EVACUATION SYSTEM OES ELITE Telescopes, Protective Tube Disposable Loop Electrodes Bandage scissors Ear scissors Laryngeal scissors Iris scissors Ligature scissors Strabismus scissors Ethmoid scissors Wire curring scissors Nasal scissors Rhinoplasty scissors Tonsil scissors Dissection scissors Visera Elite II Endoeye 3D ULTRA Telescopes (Arthroscopes) CELON ELITE ESG-200 Resection Electrodes With HF Cable Operation laryngoscope Inserter, for T-Tubes Ear forceps, inserter for ventilation tubes OLYMPUS NASAL AND SINUS ENDOSCOPES MNA-120 ENC DP AUDIO Hysteroscopic Sheath P50 Hand Switching ULTRA Telescopes (Sinuscopes) Vide ureteroscope Sheehy Weapon Sheehy Flap Knife Infant resectoscope ESG-100, AFU-100 Disposable Lap. Electrodes Resection Electrodes with HF cable Unipolar Optical Biopsy Forceps Cystofiberscope and nephrofiberscope VMC-3 VMC accessories HF Resection Electrode Tubing, sterile, for UHI smoke evacuation Suprapubic flow controller Grasping Forceps Neuroscopes CELON ENT SYSTEM HiCura Hand Instruments VERSAPOINT GENERATOR FOOTSWITCH (SMALL) BALL ELECTRODE (5 PACK) SPRING ELECTRODE (5 PACK) TWIZZLE ELECTRODE (5 PACK) MAXPASS BILIARY CATHETER PKS PlasmaSORD Electrosurgical Generator ESG-400 and Accessories Mini PCNL-System LPS electrode; Suction electrode Working Elements and insert VAPRFLEX END EFFECT (FLEX END EFFECT) MCEND0550 OES LAPARO-THORACO VIDEOSCOPE (RIGID) HD Endoeye

Establishment Types

Repack or Relabel Medical Device