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Sign in to claim this brandWhat Pearl Technology AG makes
Pearl Technology AG manufactures radiological positioning devices, including headrests and body-part positioners designed for imaging procedures. Their product line also includes single-use medical drapes and customizable foam and vacuum-formed cushions and plates for patient support and immobilization, such as the ProBelt 200 Thorax PFW and various PearlFit Wedge and Cushion models. Additional items like the FoamFit Plate and MRI-compatible ProBelt 140 MRI P are tailored for specific clinical applications.
These devices fall under Class I regulatory classification in the U.S., indicating they pose minimal risk and are subject to general controls. The products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pearl-technology.ch
- —
- —
- [email protected]
- Phone
- +41435350840
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 480151859
Catalogue (153)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProFoam Wedge 18x25x12 DS | ProFoam Wedge 18x25x12 DS | FDA UDI | Class I | Active |
| CT Table Cover 2170 S46 | CT Table Cover 2170 S46 | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x70x3 DSRGP | FDA UDI | Class I | Active |
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