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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 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PearlFit Cushion 50x30x7 | PearlFit Cushion 50x30x7 | FDA UDI | Class I | Active |
| Crania Adult | Crania Adult | FDA UDI | Class I | Active |
| CT Table Cover 2630 G | CT Table Cover 2630 G | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x60x3 DSGP | FDA UDI | Class I | Active |
| Cover Multipad | Cover Multipad | FDA UDI | Class I | Active |
| ProFoam Wedge 18x25x7 DS | ProFoam Wedge 18x25x7 DS | FDA UDI | Class I | Active |
| Multipad Bendy | Multipad Bendy | FDA UDI | Class I | Active |
| PearlFit Cushion 200x75x5 Vac | PearlFit Cushion 200x75x5 Vac | FDA UDI | Class I | Active |
| CT Table Cover 2450 P | CT Table Cover 2450 P | FDA UDI | Class I | Active |
| PearlFit Flex 3 | PearlFit Flex 3 | FDA UDI | Class I | Active |
| PearlFit Cushion 130x60x10 | PearlFit Cushion 130x60x10 | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 225x55x3 CLX | FDA UDI | Class I | Active |
| ProFoam Wedge 18x11x5 | ProFoam Wedge 18x11x5 | FDA UDI | Class I | Active |
| CT Table Cover 2190 S46 | CT Table Cover 2190 S46 | FDA UDI | Class I | Active |
| CT Table Cover 2220 P | CT Table Cover 2220 P | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x70x3 DSG | FDA UDI | Class I | Active |
| ProFoam Wedge 18x11x5 DS | ProFoam Wedge 18x11x5 DS | FDA UDI | Class I | Active |
| MR Safety Pad | ProFoam MR Safety Angel Pad | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x60x3 DSRGP | FDA UDI | Class I | Active |
| ProFoam Wedge 18x25x12 | ProFoam Wedge 18x25x12 | FDA UDI | Class I | Active |
| ProFoam Wedge 36x25x12 DS | ProFoam Wedge 36x25x12 DS | FDA UDI | Class I | Active |
| ProBelt 350 Wrap | ProBelt 350 Wrap | FDA UDI | Class I | Active |
| ProFoam Wedge60x25x12 DS | ProFoam Wedge60x25x12 DS | FDA UDI | Class I | Active |
| pearltec | Positioning KIT IS Advanced | FDA UDI | Class I | Active |
| pearltec | Positioning KIT DXR Advanced | FDA UDI | Class I | Active |
| ProFoam Wedge 26x25x7 DS | ProFoam Wedge 26x25x7 DS | FDA UDI | Class I | Active |
| ProBelt 200 Thorax PFC | ProBelt 200 Thorax PFC | FDA UDI | Class I | Active |
| PearlFit Inlay Head | PearlFit Inlay Head | FDA UDI | Class I | Active |
| PearlFit Cushion 130x50x10 Vac | PearlFit Cushion 130x50x10 Vac | FDA UDI | Class I | Active |
| FoamFit Plate 30x10x2 | FoamFit Plate 30x10x2 | FDA UDI | Class I | Active |
| pearltec | Sandbag 30x20, 2 kg | FDA UDI | Class I | Active |
| PearlFit Roll 50 | PearlFit Roll 50 | FDA UDI | Class I | Active |
| ProBelt 200 T5 | ProBelt 200 T5 | FDA UDI | Class I | Active |
| CT Table Cover 270 G | CT Table Cover 270 G | FDA UDI | Class I | Active |
| PearlFit Flex 6 | PearlFit Flex 6 | FDA UDI | Class I | Active |
| PearlFit Cushion 27x6x1 | PearlFit Cushion 27x6x1 | FDA UDI | Class I | Active |
| CT Table Cover 2070 | CT Table Cover 2070 | FDA UDI | Class I | Active |
| Multipad Standard | Multipad Standard | FDA UDI | Class I | Active |
| PearlFit Cushion 30x20x4 | PearlFit Cushion 30x20x4 | FDA UDI | Class I | Active |
| CT Table Cover 1860 | CT Table Cover 1860 | FDA UDI | Class I | Active |
| ProFoam Plate 32x32x5 DS | ProFoam Plate 32x32x5 DS | FDA UDI | Class I | Active |
| pearltec | Positioning KIT IS Basic | FDA UDI | Class I | Active |
| PearlFit Cushion 50x20x4 | PearlFit Cushion 50x20x4 | FDA UDI | Class I | Active |
| CT Table Cover 2700 P44 | CT Table Cover 2700 P44 | FDA UDI | Class I | Active |
| ProBelt 200 Extension | ProBelt 200 Extension | FDA UDI | Class I | Active |
| ProBelt 50 VH | ProBelt 50 VH | FDA UDI | Class I | Active |
| ProFoam Wedge 26x25x7 | ProFoam Wedge 26x25x7 | FDA UDI | Class I | Active |
| ProBelt 50 VL | ProBelt 50 VL | FDA UDI | Class I | Active |
| ProBelt 50VL Kit | ProBelt 50VL Kit | FDA UDI | Class I | Active |
| pearltec | ProBelt 350 U5 | FDA UDI | Class I | Active |
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