FDA Registration
Active
🇩🇪 Germany
KUNSTSTOFF HELMBRECHTS AG
Reg #: 3008439484
·
FEI: 3008439484
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- KUNSTSTOFF HELMBRECHTS AG
- Registration Number
- 3008439484
- FEI Number
- 3008439484
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Pressecker Str. 39
- City
- Helmbrechts Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- Kunststoff Helmbrechts AG
- Operator Number
- 10059824
- Address
- Pressecker Str. 39
- City
- Helmbrechts
- State
- DE-NOTA
- Postal Code
- 95233
- Country
- DE
US Agent
- Business Name
- confinis USA Inc.
- Contact Name
- Alfred Lerch
- Address
- 600 Park Offices Drive Suite 300, Unit #50
- City
- Durham
- State
- NC
- ZIP
- 27709
- Country
- US
- [email protected]
- Phone
- 910 2289391
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2020-02-03 |
| Esophagoscope (Flexible Or Rigid) | EOX | Class 2 | Ear, Nose, Throat | No | 2020-02-03 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2019-02-27 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2022-01-25 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2022-01-25 |
Proprietary Names
CMOS Video Rhino-Laryngoscope SSU
CMOS Video Esophagoscope SSU
Intubation video endoscope FIVE-S
Flexible Intubation Video Endoscope Sterile (FIVE-S)
Flexible Video-Uretero-Renoscope SSU System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)