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US
Last updated May 31, 2026
What Quest Projects B.V. makes
Quest Projects B.V. manufactures rigid optical and video laparoscopes, which are used for minimally invasive surgical procedures, as well as surgical microscopes equipped for fluorescent angiography. Their product line includes modular systems and kits designed for both laparoscopic and open surgical applications, supporting visualisation and diagnostic imaging in operating rooms.
The company’s devices fall under Class II regulatory classification in the US, with products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, adhering to applicable regulatory requirements for surgical imaging and endoscopic tools.
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 Quest Projects B.V. manufacture?
Quest Projects B.V. specialises in surgical imaging tools, including rigid optical laparoscopes, rigid video laparoscopes, and surgical microscopes with fluorescent angiography capabilities. These devices are designed for minimally invasive procedures, such as laparoscopic surgery, as well as open surgical applications, enabling precise visualisation and diagnostic imaging in clinical settings.
Where is Quest Projects B.V. based, and does this affect its regulatory standing?
Quest Projects B.V. is based in the United States. Its regulatory standing is determined by the individual devices it manufactures, not the company itself. The devices fall under Class II classification in the US, meaning they undergo specific regulatory oversight to ensure safety and performance before being authorised for market.
Are Quest Projects B.V.’s devices listed in any regulatory registries?
Yes, Quest Projects B.V.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a standardised code, ensuring transparency and traceability for healthcare providers and regulators.
How are Quest Projects B.V.’s devices classified under US regulations?
Quest Projects B.V.’s devices are classified as Class II under US regulatory guidelines. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness before authorisation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- quest-mi.com
- —
- —
- [email protected]
- Phone
- 8443916596
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 386614502
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Quest Spectrum Platform | ART-SYS-0019 | FDA UDI | Class II | Active |
| Quest Spectrum Kit for open surgery | ART-ICG-0001 | FDA UDI | Class II | Active |
| Quest Laparoscope | ART-LAP-0007 | FDA UDI | Class II | Active |
| Quest Laparoscope | ART-LAP-0006 | FDA UDI | Class II | Active |
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