FDA Registration Active 🇩🇪 Germany

HEBUMEDICAL GMBH

Reg #: 9611112 · FEI: 3008782585 · Expires 2026
Products
227
Proprietary Names
366
Establishment Types
4
Classifications
227

Registration Details

Registration Name
HEBUMEDICAL GMBH
Registration Number
9611112
FEI Number
3008782585
Status
Active
Expiry Year
2026
Initial Importer
No
Address
BADSTRASSE 8
City
TUTTLINGEN Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K974493

Owner / Operator

Firm Name
HEBUMEDICAL GMBH
Operator Number
8010320
Address
BADSTRASSE 8, --
City
TUTTLINGEN
State
DE-NOTA
Postal Code
78532
Country
DE
Correspondent
THOMAS - BUTSCH

US Agent

Business Name
BUSINESS SUPPORT INTERNATIONAL
Contact Name
Randolph Scherp
Address
1350 Avenue Of The Americas FL 2
City
New York
State
NY
ZIP
10019
Country
US
Phone
212 3318358

Products

Device Name Product Code
Laparoscopic Accessories, Gynecologic NWV
Handpiece (Brace), Drill HBD
Blade, Saw, General & Plastic Surgery, Surgical GFA
Punch, Surgical LRY
Plate, Fixation, Bone HRS
Screw, Fixation, Bone HWC
Guide, Needle, Surgical GDF
Forceps, Dressing, Dental EFL
Orthopedic Stereotaxic Instrument OLO
Holder, Needle, Gastroenterologic FHQ
Instrument, Ent Manual Surgical LRC
Stripper, Vein, Reusable GAI
Colonoscope And Accessories, Flexible/Rigid FDF
Duodenoscope And Accessories, Flexible/Rigid FDT
Accessories, Photographic, For Endoscope (Exclude Light Sources) FEM
Gastroscope And Accessories, Flexible/Rigid FDS
Sigmoidoscope And Accessories, Flexible/Rigid FAM
Nipper, Malleus JYR
Forceps, Wire Holding HYA
Hook, Surgical, General & Plastic Surgery GDG
Gauge, Measuring JYJ
Shield, Protective, Personnel KPY
Chisel, Nasal KAN
Mirror, Ent KAI
Excavator, Ear JYH
Source, Carrier, Fiberoptic Light EQH
Packer, Uterine HDM
Hemostat HRQ
Extractor HWB
Tenaculum, Uterine HDC
Accessories, Implant, Dental, Endosseous NDP
Electrosurgical, Cutting & Coagulation & Accessories GEI
Chisel, Surgical, Manual FZO
Knife, Ent KTG
Mirror, Mouth EAX
Elevator, Surgical, Dental EMJ
Retractor, Self-Retaining, For Neurosurgery GZT
Clamp, Vascular DXC
Instrument, Manual, Specialized Obstetric-Gynecologic KNA
Clamp, Non-Electrical FFN
Rasp, Surgical, General & Plastic Surgery GAC
Scissors, General, Surgical LRW
Scaler, Periodontic EMN
Specula Accessories FXG
Clip, Removable (Skin) FZQ
Hysteroscope Accessories NWW
Pick, Microsurgical Ear JYT
Remover, Crown EIS
Caliper KTZ
Camera, Cine, Endoscopic, Without Audio FWL
Knife, Ophthalmic HNN
Cutter, Surgical FZT
Dynamometer, Nonpowered HRW
Forceps, Biopsy, Gynecological HFB
Speculum, Vaginal, Metal HDF
Curette, Surgical, Dental EMK
Retractor, Self-Retaining FFO
Scissors, Ophthalmic HNF
Instrument, Cast Removal, Ac-Powered LGH
Instrument, Microsurgical GZX
Handle, Scalpel GDZ
Syringe, Ent KCP
Snare, Nasal KBE
Snare, Non-Electrical FGX
Needle, Suturing, Reusable GDL
Catheter And Tip, Suction JOL
Saw HSO
Needle, Aspiration And Injection, Reusable GDM
Retractor, Non-Self-Retaining FGN
Instrument, Manual, Surgical, General Use MDM
Accessories, Catheter KGZ
Press, Vein JYW
Saw, Nasal KBC
Scissors, Nasal KBD
Rongeur HTX
Forceps, Surgical, Gynecological HCZ
Instrument, Ligature Passing And Knot Tying HCF
Depressor, Metal Tongue, Surgical KBL
Probe, Lachrymal HNL
Clamp, Penile FHA
Adenotome KBH
Specula, Ophthalmic HNC
Table And Attachments, Operating-Room BWN
Rack, Clip HBR
Ring Cutter FNS
Expander, Surgical, Skin Graft FZW
Instrument, Manual, General Obstetric-Gynecologic KOH
Osteotome HWM
Knife, Ear JYO
Clamp, Uterine HGC
Bit, Drill HTW
Instrument, Cutting, Orthopedic HTZ
Orthopedic Manual Surgical Instrument LXH
Rod, Measuring Ear JYZ
Hook, Microsurgical Ear JYL
Halter, Head, Traction HSS
Elevator, Ent KAD
Mallet HXL
Hook, Ophthalmic HNQ
Dilator, Lachrymal HNW
Stripper, Surgical HRT
Bistoury, Tracheal KCC
Marker, Skin FZZ
Cutter, Wire HXZ
Laparoscope, General & Plastic Surgery GCJ
Forceps, Rongeur, Surgical EMH
Dissector, Tonsil KBM
Contractor, Surgical FZR
Retractor, Ophthalmic HNI
Snare, Ear JZD
Clamp, Ossicle Holding JYF
Osteotome, Manual GFI
Guide, Surgical, Instrument FZX
Accessories, Arthroscopic NBH
Basin, Emesis FNY
Speculum, Ent EPY
Clamp, Cannula FKC
Hook, Tracheal KCH
Passer HWQ
Scoop FHL
Scissors, Umbilical HDJ
Probe, Ent KAK
Forceps, Ent KAE
Elevator HTE
Curette HTF
Needle, Gastro-Urology FHR
Dilator, Tracheal KCG
Applier, Hemostatic Clip HBT
Clamp, Circumcision HFX
Accessories, Cleaning Brushes, For Endoscope MNL
Retractor, Vaginal HDL
Speculum, Rectal FFQ
Clamp, Surgical, General & Plastic Surgery GDJ
Scissors, Surgical Tissue, Dental EGN
Spatula, Surgical, General & Plastic Surgery GAF
Snare, Tonsil KBZ
Mobilizer, Ent KAJ
Sound, Uterine HHM
Curette, Nasal KAP
Arthroscope HRX
Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
Instrument, Catheter, Punch FEX
Stylet, Surgical, General & Plastic Surgery GAH
Sound, Urethral, Metal Or Plastic FBX
Curette, Surgical, General Use FZS
Spud, Ophthalmic HNA
Screwdriver HXX
Dilator, Cervical, Fixed Size HDQ
Curette, Uterine HCY
Retractor, Ent KAL
Saw, Electrically Powered DWI
Fork, Tuning GWX
Pinwheel GWY
Trocar, Tracheal KCI
Instruments, Dental Hand DZN
Tube, Ear Suction JZF
Loop, Wire JYQ
Instruments, Surgical, Cardiovascular DWS
Ligator, Hemorrhoidal FHN
Instrument, Surgical, Non-Powered HAO
Gauge, Depth, Instrument, Dental EIL
Ring, Laparotomy FHI
Rasp, Nasal KBA
Instrument, Bending Or Contouring HXP
Amniotome HGE
Surgical Instruments, G-U, Manual (And Accessories) KOA
Drills, Burrs, Trephines & Accessories (Manual) HBG
Block, Cutting, Ent, Non-Sterile NNR
Twister, Wire HXS
Tonsillectome KCA
Knife, Tonsil KBQ
Curette, Ear JYG
Forceps, General & Plastic Surgery GEN
Probe HXB
Tape, Measuring, Rulers And Calipers FTY
Impactor HWA
Holder, Needle; Orthopedic HXK
Rasp HTR
Scissors, Episiotomy HDK
Probe, Rectal, Non-Powered EXX
Gouge, Nasal, Ent KAQ
Cannula, Surgical, General & Plastic Surgery GEA
Knife, Surgical EMF
Plier, Orthodontic JEX
Instrument, Cast Application/Removal, Manual LGG
Knife, Amputation GDN
Trocar, Ent KTE
Laryngoscope, Rigid CCW
Forceps, Biopsy, Non-Electric FCL
Speculum, Non-Illuminated FXE
Tourniquet, Nonpneumatic GAX
Stethoscope, Manual LDE
Curette, Adenoid KBJ
Caliper, Ophthalmic HOE
Tamp HXG
Carrier, Ligature GEJ
Support, Patient Position CCX
Gag, Mouth KBN
Punch, Ent KTF
Knife, Nasal KAS
Otoscope ERA
Carver, Wax, Dental EIK
Punch, Antrum KAW
Camera, Television, Microsurgical, Without Audio FWD
Tray, Surgical, Instrument FSM
Rasp, Ear JYY
Saw, Manual And Accessories GDR
Bar, Preformed EHO
Knife, Orthopedic HTS
Forceps HTD
Dissector, Surgical, General & Plastic Surgery GDI
Applier, Surgical, Clip GDO
Chisel, Middle-Ear JYE
Probe And Director, Gastro-Urology FGM
Scissors, Ear JZB
Clamp HXD
Magnet, Permanent HPN
Goniometer, Nonpowered KQW
Curette, Ophthalmic HNZ
Gauge, Depth HTJ
Tap, Bone HWX
Tonometer, Manual HKY
Retractor GAD
Device, Locking, For Intestinal Clamp FFR
Retractor, Fiberoptic FDG
Elevator, Surgical, General & Plastic Surgery GEG
Forceps, Ophthalmic HNR

Proprietary Names

Knot Pusher Laparoscopic Accessories, Gynecologic Hudson Blade, Saw, General & Plastic Surgery Punch, Surgical Pin Distractor, threaded, 2,8mm Guide, Needle, Surgical Forceps, Dressing, Dental Robotic Integration Scalpel Holder 17-1092TC 18-1832A-TC 17-1090TC 17-1091TC Holder, Needle Instrument, ENT Manual Surgical Needle Holder Dressing Forceps Artery Forceps Haemostatic Forceps Various Models of Reusable Vein Strippers Stripper, Vein, Reusable Micro Camera Cable Micro Camera Nail Nipper Wire Holding Forceps Hook, Surgical, General & Plastic Surgery GAUGE 1352286 PISTON TRIMMING Special Skin Hook Chisel, Nasal HOUSE-HOUGH EXCAVATOR, 6-1/2, ANGLED 90DEGREES Light Source Adapter Light cable Packer, Uterine Hemostatic Forceps Hemostat Extractor Tenaculum, Uterine cable bipolar Chisel, Surgical, Manual Freer musous knife Converse rhinoplastic and nasal knife, 17,5cm, 6 3/4" Laryngeal mirror, cone socket, magnifying Elevator, Surgical, Dental Jansen & Other Scalp Retractor, Self-Retaining for Neurosurgery DeBakey Bulldog clamp Cooley hemostatic forceps DeBakey hemostatic forceps Cooley Bulldog clamp DeBakey Multi-Purpose-Clamp Cooley Multi-Purpose Clamp Cooley vein clamp DeBakey vein clamp DeBakey Vascular Clamp DELEE CERVICAL FORCEPS 9" Clamp, non-electrical POLLCK-DNGMN SEPTAL DISPL POLLOCK-DINGMAN DISPLACER 8 Scissors, General & Plastic Surgery Scaler, Periodontic BLADE 1352282 O/R TABLE BRACKET MOUNT 1352277 QUICK-LOCK SPECULUM ARM 1362275 UNIVERSAL FLEXIBLE Clip, Removable, Skin Hysteroscopy Instruments Pick, Microsurgical Ear Remover, Crown SLIDE CALIPERS OF STAINLESS STEEL SYNTHETIC MATERIALS Caliper, Clinical All-in-one Unit CAMLIGHT Navigated 4mm up angled Curette Navigated 4mm down biting Curette Navigated 6mm up angled Curette Navigated 6mm angled ring Curette Knife, Ophthalmic NAIL SPLITTING SCISSORS Cutter, Surgical Dynamometer, Nonpowered Forceps, Biopsy, Gynecological Speculum, Vaginal, Metal Vaginal Specula, and others KOGAN Endospecula, Trimmer Retractor, Selt-Retaining Scissors, Ophthalmic Instrument, Cast Removal, AC-Powered Instrument, Microsurgical Scalpel handle Syringe Snare, Nasal Snare, Non-Electrical Needle, Suturing, Reusable Suction Tube Saw Needle, Aspiration and Injection, Reusable Retractor, Non-Self-Retaining Instrument, Manual, General Surgery Accessories, Catheter House cartilage crusher Saw, Nasal Scissors, Nasal Rongeur Ferris-Smith Ronguer Kerrison Rongeur Handle for Kerrison-Rongeur, Laminectomy punch Rotatable Kerrison laminectomy punch Gordon Vulsellum Forceps SChroeder Uterine Vulsellum Kelly Vulsellum Forceps Laufe Uterine Polypus forceps Billroth Tumor FCPS Overstreet Endo Polyp Forceps Henrotin Vul Forceps Somers Uterine Elev Forceps Long Hysterectomy Forceps Museux Uterine Vulsellum Jacobs Uterine Vulsellum Teale vulsellum forceps Instrument, Ligature Passing & Knot Tying Depressor, Metal Tongue, ENT PROBE Clamp, Penile Adenotome Specula, Ophthalmic WORKTABLE 1352285 HUBBARD W/BRACKET Rack, Clip Cutter, Ring Instruments, Manual, General Obstetric-Gynecologic SIL OSTEO W/GRD 6-3/4 STR 4MM SIL OSTEO W/GRD 6-3/4 RT 4MM SIL OSTEO W/GRD 6-3/4 LT 4MM 8mm Osteotome straight TYMPANUM KNIVES HYSTERECTOMY FORCEPS uterine forceps Drills Instrument, Cutting, Orthopedic Joker Elevator ORTHOPEDIC MANUAL SURGICAL Scalpel Holder Instrument, Orthopedic, Manual Surgical Thread Clip House Mess-Sonde Hook, Microsurgical, Ear Halter, Head, Traction ELEVATOR Elevator, ENT Mallet PERCUSSION HAMMERS Hook, Ophthalmic Dilator, Lachrymal Stripper, Surgical JACKSON TRACHEAL BISTOURY, 7, CURVED BLADE Freeman Areola Markers, Grossman Areola Markers McKissock Breast Markers, Marker, Skin Cutter, Wire Uterine Tenaculum Forceps FORCEPS Forceps, Rongeur, Surgical PHANEUF CLAMP CURVED 8 1/2" Uterine Vulsellum Forceps, Various Models Forceps, Surgical, Gynecological Dissector, Tonsil Contractor, Surgical Retractor, Ophthalmic Snare, Ear ossicle holding clamp MICRO-WORKTABLE OSSICLE HOLDING CLAMP Osteotome, Manual Guide, Surgical, Instrument Accessories, Arthroscopic Bowl stainless steel Speculum, ENT Clamp, Cannula Hook, Tracheal TENDON PASSING INSTRUMENTS Passer Gall stone scoop Scissors, Umbilical Ostium Seeker MINI BULLDOG STRAIGHT 4MM MINI BULLDOG STRAIGHT 6MM MICRO BULLDOG STRAIGHT 7MM MINI BULLDOG CURVED 7MM MICRO BULLDOG ANGLED 9MM SAROT ARTERY CLAMP MED 7 1/2" MICRO BULLDOG APPLYING FORCEP MICRO BULLDOG SLIGHT CURVE 9MM MICRO BULLDOG STRAIGHT 8MM Forceps, ENT Elevator Down pushing curette 4mm Penfield, 2mm, pull, straight Navigated Curette Curette Needle, Gastro-Urology Dilator, Tracheal APPLYING AND REMOVING FORCEP Applier, Hemostatic Clip Clamp, Circumcision, Bell Brushes Ellik Evacuator Tube to Ellik Evacuator Connector Stopcock with male luer lock Retractor, Vaginal RETAL SPECULA Clamp, Surgical, Gen. & Plast. Surg. Skene, Staude-Moore, Czerny, and other models Schroder, Teale, Jakobs, Museux Duplay, Schroder-Braun, Braun, Scissors, Surgical Tissue, Dental Spatula, Surgical, Gen. & Plastic Surgery Snare, Tonsil Derlacki Mobilizer Sound, Uterine Arthroscope Endoscope sleeve Kerrison-Rongeur Remover, Intrauterine Device, Contraceptive, hook-Type Sponge and Dissecting Forceps Dissecting Forceps, with ratchet Grasping Forceps, S-shaped Catheter Punch Stylet Sound, Urethral, Metal or Plastic Curette-Excavator HOUSE CUR 7 D/E STRG-ANG HOUSE STAPES CUR 6 D/E ANG 35D HOUSE CUR 7 D/E LGHT-ANG Spud, Ophthalmic Screwdriver Dilator, Cervical, Fixed Size Curette, Uterine Retractor, ENT Saw, Electrically Powered Tuning Fork NEUROLOGICAL PINWHEEL Trocar, Tracheal Instruments, Dental Hand SPATULA/PACKER AND OTHERS MATRIX WAXER HEBU Micro Suction Tubes ROSEN SUCTION TUBE BARON SUCTION TUBE Tube, Ear Suction Loop, Wire Instruments, Surgical, Cardiovascular Ligator HEBU Neuroline Suction Tubes Micro Vessel Knives, F5-9009-000 Instruments, Surgical, Non-Powered Gauge, Depth, Instrument, Dental Ring, Laparotomy Rasp, Nasal Bending Iron Amniotom Beacham, 26cm, 10 1/4" Surgical Instruments, G-U, manual (and accessories) Drills, Burrs, Trephines & Accessories (Manual) Teflon cutting block Twister, Wire TONSILLECTOME Knife, Tonsil Curette, Ear EAR CURETTES (DIFFERENT MODELS) Forceps, Gen. & Plastic Surgery WIDE RANGE OF GEN. PLASTIC SURGERY FORCEPS Reduction Forceps Nail instruments Fox Ball Tip Feeler Laparoscope, General & Plastic Surgery METAL RULERS MEASURING TAPES Tape, Measuring, Rulers & Calipers Impactor Rasp Scissors, Episiotomy Probe, Rectal, Non-Powered Gouge, Nasal, ENT Suction Tubes Frazier, Ferguson, Plester Finsterer Suction/Irrigation Tubes, De Bakey Suction Tubes, Cannula, Surgical, General & Plastic Surgery Curettes Knife, Surgical Plier, Orthodontic Instrument, Cast Application/Removal, Manual AMPUTATING KNIVES Trocar and canula Laryngoscope, Rigid Forceps, Biopsy, Non-Electric Speculum, Non-Illuminated Tourniquet, Nonpneumatic Stethoscope, Manual Curette, Adenoid CALIPER Caliper, Ophthalmic Carrier, Ligature Support, Patient Position Gag, Mouth Thoracosope Punch, ENT MULTPLE Knife, Nasal Otoscope Carver, Wax, Dental Punch, Antrum SURGICAL INSTRUMENT BASKET Tray, Surgical, Instrument RASP Rasp, Ear Saw, Manual and Accessories Bar, Performed Knife, Orthopedic Forceps Dissector, Surgical, Gen. & Plastic Surgery applier, surgical, clip Chisel, Middle-Ear Probe and Director, Gastro-Urology Scissors, Ear Micro Bulldog Plate Holding and Reduction Clamp Clavicle Clamp Eye Magnetic and Foreign Body Loop, 4 3/4" Magnet, Permanent Goniometer, Nonpowered Curette, Ophthalmic Gauge, Depth Cloward depth gauge CH1630 CH5091 COOLEY V. MUELLER AORTA CLAMP CH5090 DAVIDSON PULMONARY VESSEL V. MUELLER VENA CAVA CLAMP CLAMP CARDIO COOLEY JAW SATINSKY VENA CAVA CLP 10-1/4 CH6376 GEMINI CLAMP 5-1/2 Tap, bone Schioetz tonometer Nerve Root Retractor, rigid, 5mm RETRACTORS FOR GENERAL & PLASTIC SU VARIOUS TYPES AND MODELS DELS Ring Curette, angled, 6mm Retractor, Surgical, Gen. & Plastic Surgery Retractor Device, Locking, for Intestinal Clamp CLAMP CLOSING FORCEPS Adson Drill Guide and Dura Protector Retractor, Fiberoptic Elevator, Gen. & Plastic Surgery Forceps, Ophthalmic

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device