FDA Registration
Active
🇩🇪 Germany
INVIDIA MEDICAL GMBH U CO KG
Reg #: 3010399422
·
FEI: 3010399422
·
Expires 2026
Products
74
Proprietary Names
4
Establishment Types
1
Classifications
74
Registration Details
- Registration Name
- INVIDIA MEDICAL GMBH U CO KG
- Registration Number
- 3010399422
- FEI Number
- 3010399422
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carl-Benz-Str. 28
- City
- Emmingen-Liptingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K080560
Owner / Operator
- Firm Name
- INVIDIA Medical GmbH u CO KG
- Operator Number
- 10046503
- Address
- Carl-Benz-Str. 28
- City
- Emmingen-Liptingen
- State
- Baden-Wurttemberg
- Postal Code
- 78576
- Country
- DE
- Correspondent
- Michael Hainke
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 |
|---|---|---|---|---|---|
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2016-11-29 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2016-11-29 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2016-11-29 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2014-11-03 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2016-03-10 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2018-08-30 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2016-11-30 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2022-09-05 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2014-11-03 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2016-11-29 |
| Light, Fiber Optic, Dental | EAY | Class 1 | Dental | No | 2018-08-30 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2016-11-29 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2016-11-29 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2016-11-29 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2019-12-03 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2018-08-30 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2018-08-30 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2016-11-29 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2016-11-29 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2016-03-08 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2016-11-29 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2016-11-29 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2016-11-29 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2016-03-10 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2022-09-05 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2022-09-05 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2014-11-03 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2016-11-29 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2016-03-08 |
| Airway Suction Kit | OFO | Class 1 | Anesthesiology | No | 2024-05-08 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2016-11-29 |
| Camera, Television, Surgical, Without Audio | FWB | Class 1 | General, Plastic Surgery | No | 2018-08-30 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2014-03-31 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2016-11-30 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2016-11-29 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2020-01-22 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2018-08-30 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2016-11-29 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2016-11-29 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2022-07-11 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2014-09-19 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2020-01-22 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2016-03-08 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Lithotriptor, Biliary Mechanical | LQC | Class 2 | Gastroenterology, Urology | No | 2020-01-22 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2022-09-05 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2016-03-08 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-06-05 |
| Probe | HXB | Class 1 | Orthopedic | No | 2016-03-10 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2016-11-29 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2014-09-16 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2016-03-08 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-11-29 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2016-11-29 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2020-01-22 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2020-05-14 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2016-11-30 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2016-03-10 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2016-11-29 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2016-11-29 |
Proprietary Names
PREMIUM UHD 4K ARTHRO/SINUSCOPE 175MM/70 /4MM
Laparoscope, General and Plastic Surgery
Luer-Lock tube connector
Luer-lock tube connector with stopcock
Establishment Types
Repack or Relabel Medical Device