FDA Registration
Active
🇩🇪 Germany
asap endoscopic products GmbH
Reg #: 3008494403
·
FEI: 3008494403
·
Expires 2026
Products
8
Proprietary Names
15
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- asap endoscopic products GmbH
- Registration Number
- 3008494403
- FEI Number
- 3008494403
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Stoeckmatten19
- City
- Umkirch Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K032822
Owner / Operator
- Firm Name
- asap GmbH
- Operator Number
- 10023512
- Address
- asap endoscopic products GmbH, Stoeckmatten19
- City
- Umkirch
- State
- Baden-Wurttemberg
- Postal Code
- 79224
- Country
- DE
- Correspondent
- Xin Zhou
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2007-11-28 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2009-11-13 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2007-11-28 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2026-06-12 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2007-11-28 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2007-11-28 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-11-28 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2009-11-13 |
Proprietary Names
Otoscope ENT
asap TV-Adapter
Multifunction Video/Motionsystem
asap Sinuscope
Hysteroscopes
asap Oesophagoscope
asap Laryngoscope
asap Cystoscope
asap Laparoscope
asap Arthroscope
asap Hysteroscope
asap gyn Laparoscope
Multiscopes
asap spine systems®
TV-Adapter
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)