Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAMNOTEC International Medical GmbH
US
Last updated May 27, 2026
What AMNOTEC International Medical GmbH makes
AMNOTEC International Medical GmbH manufactures stationary digital general-purpose fluoroscopic x-ray systems and rigid optical laparoscopes. The company also produces electromechanical device and system transport trolleys.
The company is based in the US and maintains a portfolio consisting of Class I and Class II medical devices. These products are listed within the FDA UDI database.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AMNOTEC International Medical GmbH manufacture?
AMNOTEC International Medical GmbH specializes in three primary categories of medical devices: stationary general-purpose fluoroscopic x-ray systems (digital), rigid optical laparoscopes, and electromechanical device/system transport trolleys. These products are designed for use in clinical settings where imaging, minimally invasive procedures, and efficient device transport are required.
Where is AMNOTEC International Medical GmbH based?
The company is headquartered in the United States. This location likely influences its regulatory compliance processes, particularly for devices marketed in the US market, such as those listed in the FDA’s UDI database.
Which regulatory registries list AMNOTEC’s medical devices?
AMNOTEC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the United States, ensuring traceability and compliance with regulatory requirements.
How are AMNOTEC’s medical devices classified under regulatory standards?
AMNOTEC’s devices fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 342569940
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amnotec | 71-088-27 NIR | FDA UDI | Class II | Active |
| Amnotec | 72-405-30-US | FDA UDI | Class II | Unknown |
| Amnotec | 72-405-30-US | FDA UDI | Class II | Unknown |
| Amnotec | 71-705-52 NIR TT | FDA UDI | Class I | Unknown |
| Amnotec | 71-068-10 NIR | FDA UDI | Class II | Active |
| Amnotec | 72-405-00-US | FDA UDI | Class II | Unknown |
| Amnotec | 72-410-00-US | FDA UDI | Class II | Unknown |
| Amnotec | 71-088-23 NIR | FDA UDI | Class II | Active |
| Amnotec | 72-410-00-US | FDA UDI | Class II | Unknown |
| Amnotec | 72-405-00-US | FDA UDI | Class II | Unknown |
| Amnotec | 71-182-30 NIR | FDA UDI | Class II | Unknown |
| Amnotec | 71-068-05 NIR | FDA UDI | Class II | Active |
| Amnotec | 72-410-00 NIR | FDA UDI | Class II | Active |
| Amnotec | 71-705-46 | FDA UDI | Class I | Unknown |
| Amnotec | 72-405-30 NIR | FDA UDI | Class II | Active |
| Amnotec | 71-088-20 NIR | FDA UDI | Class II | Active |
| Amnotec | 72-410-30-US | FDA UDI | Class II | Unknown |
| Amnotec | 71-146-30 NIR C-US | FDA UDI | Class II | Unknown |
| Amnotec | 72-410-30 NIR | FDA UDI | Class II | Active |
| Amnotec | 71-089-30 NIR | FDA UDI | Class II | Active |
| Amnotec | 72-405-00 NIR | FDA UDI | Class II | Active |
| Amnotec | 72-410-30-US | FDA UDI | Class II | Unknown |
| Amnotec | 71-705-52 NIR TT | FDA UDI | Class I | Active |
| Amnotec | 71-182-30 NIR | FDA UDI | Class II | Unknown |
| Amnotec | 71-705-46 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.