Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat QuestAlpha GmbH & Co. KG makes
QuestAlpha GmbH & Co. KG manufactures sterile ophthalmic sponges, non-biodegradable intranasal splints, and surgical scrub sponges. Their product line includes items like Sugi strips and sheets, Sugi Rhino Swabs, and Endopads, designed for single-use medical procedures.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for medical device authorisation.
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 QuestAlpha GmbH & Co. KG manufacture?
QuestAlpha GmbH & Co. KG specialises in sterile medical devices primarily used in surgical and diagnostic procedures. Their product line includes ophthalmic sponges (such as Sugi strips and sheets), non-biodegradable intranasal splints (e.g., Sugi Rhino Swabs), and surgical scrub sponges. These devices are designed for single-use applications to ensure hygiene and safety in clinical settings.
Where is QuestAlpha GmbH & Co. KG based, and how does this affect its devices?
QuestAlpha GmbH & Co. KG is based in the United States. Since the company operates within the US, its devices must comply with FDA regulations, including classification under FDA’s risk-based system (Class I or Class II) and registration in the FDA’s Unique Device Identifier (UDI) database. This ensures traceability and adherence to US medical device authorisation requirements.
Which regulatory registries list QuestAlpha GmbH & Co. KG’s devices?
QuestAlpha GmbH & Co. KG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system provides a standardised way to identify medical devices throughout their distribution and helps ensure transparency and traceability in regulatory oversight. This listing is essential for tracking devices like Sugi strips, Endopads, and Rhino Swabs under FDA’s authorisation framework.
How are QuestAlpha GmbH & Co. KG’s devices classified under FDA regulations?
QuestAlpha GmbH & Co. KG’s devices fall into FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls (e.g., good manufacturing practices), while Class II devices involve moderate risk and may need special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and regulatory history, as outlined in FDA’s device classification system.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- questalpha.com
- —
- —
- [email protected]
- Phone
- +4927747050
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 342894795
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sugi | 31963 | FDA UDI | Class II | Active |
| Sugi | 31963 | FDA UDI | Class II | Unknown |
| Sugi | 31602 | FDA UDI | Class II | Active |
| Sugi | 30673 | FDA UDI | Class II | Active |
| Sugi | 31301 | FDA UDI | Class II | Active |
| Sugi | 30617 | FDA UDI | Class II | Active |
| Sugi Rhino Swabs and. Endopads, sterile, sample | 31784 | FDA UDI | Class I | Active |
| Sugi | 31962 | FDA UDI | Class II | Active |
| Sugi | 30652 | FDA UDI | Class II | Active |
| Sugi | 31604 | FDA UDI | Class II | Active |
| Sugi | 30622 | FDA UDI | Class II | Active |
| Sugi | 31962 | FDA UDI | Class II | Unknown |
| Sugi | 30761 | FDA UDI | Class II | Active |
| Sugi | 30672 | FDA UDI | Class II | Unknown |
| Sugi strips and sheets, sterile, sample | 31710 | FDA UDI | Class I | Active |
| Sugi | 31002 | FDA UDI | Class II | Active |
| Sugi | 32102 | FDA UDI | Class II | Active |
| Sugi | 30603 | FDA UDI | Class II | Unknown |
| Sugi | 30670 | FDA UDI | Class II | Active |
| Sugi sterile, sample, ophthalmology | 30001 | FDA UDI | Class II | Active |
| Sugi | 31004 | FDA UDI | Class II | Active |
| Sugi | 30675 | FDA UDI | Class II | Active |
| Sugi | 31005 | FDA UDI | Class II | Active |
| Sugi | 30901 | FDA UDI | Class II | Active |
| Sugi | 30653 | FDA UDI | Class II | Active |
| Sugi | 30616 | FDA UDI | Class II | Active |
| Sugi | 30671 | FDA UDI | Class II | Active |
| Sugi | 30674 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.