FDA Registration
Active
🇩🇪 Germany
RUDOLF MEDICAL GMBH + CO. KG
Reg #: 8010298
·
FEI: 3003448211
·
Expires 2026
Products
93
Proprietary Names
7
Establishment Types
2
Classifications
93
Registration Details
- Registration Name
- RUDOLF MEDICAL GMBH + CO. KG
- Registration Number
- 8010298
- FEI Number
- 3003448211
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ZOLLERSTRASSE 1
- City
- FRIDINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K073498
Owner / Operator
- Firm Name
- RUDOLF MEDICAL GMBH + CO. KG
- Operator Number
- 8010298
- Address
- ZOLLERSTRASSE 1, --
- City
- FRIDINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78567
- Country
- DE
- Correspondent
- Ayfer - Bektas
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 |
|---|---|---|---|---|---|
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1997-08-11 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2009-07-24 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2009-08-25 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 1977-12-30 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2003-08-01 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2009-08-28 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1986-05-15 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 1998-12-09 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2003-07-25 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2009-08-17 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2004-06-25 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2009-08-20 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2009-08-17 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2014-03-04 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1977-12-30 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2009-07-23 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2004-05-04 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2009-08-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2009-08-28 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2009-08-20 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1977-12-30 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 1986-05-15 |
| Clip, Aneurysm | HCH | Class 2 | Neurology | No | 2009-09-07 |
| Applier, Aneurysm Clip | HCI | Class 2 | Neurology | No | 2009-09-07 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2009-07-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2008-10-06 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2009-07-24 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2009-07-24 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2009-08-20 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1997-08-11 |
| Tonsillectome | KCA | Class 1 | Ear, Nose, Throat | No | 2009-11-13 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1986-05-15 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2009-08-28 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2009-07-21 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2004-01-06 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2011-07-06 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1977-12-30 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 1998-12-09 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2004-06-01 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2004-06-01 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2009-05-06 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2005-02-24 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2009-08-19 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2009-08-19 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2009-05-05 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2006-08-24 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1986-05-15 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1986-05-15 |
| Probe | HXB | Class 1 | Orthopedic | No | 1998-12-09 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2009-09-01 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1977-12-30 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2009-09-03 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 1986-05-15 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2004-06-01 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2009-06-08 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1986-05-15 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2010-03-23 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1986-05-15 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1986-05-15 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2004-07-07 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2009-08-19 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 1986-05-15 |
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2009-08-24 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2003-09-16 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2009-07-23 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2009-07-23 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 1986-05-15 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2004-06-18 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2013-01-29 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2009-08-17 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2009-09-03 |
| Test, Spectacle Dissociation, Battery-Powered (Lancaster) | HLO | Class 1 | Ophthalmic | No | 2013-11-12 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2009-09-03 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2003-08-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2004-03-24 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2009-09-07 |
| Applier, Cerclage | HXN | Class 1 | Orthopedic | No | 1998-12-09 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2004-03-24 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2006-08-24 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1998-12-09 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2009-04-23 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2009-09-03 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 1986-05-15 |
Proprietary Names
JOSEF SCISSORS
CLIP
DISSECTING SCISSORS
FENESTROMETER, Rosen myringotomy
Scissors Esmarch
CUSHING ELEVATOR WIDE, SHARP END ROUND EDGE ON "S" CURVED SHANK, OVERALL LENGTH 7-1/2"(19.1CM)
SCISSORS MAYO-STILLE, CURVED TC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility