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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 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CT Table Cover 2720 G | CT Table Cover 2720 G | FDA UDI | Class I | Active |
| PearlFit Cushion 50x50x5 Vac | PearlFit Cushion 50x50x5 Vac | FDA UDI | Class I | Active |
| Crania Child | Crania Child | FDA UDI | Class I | Active |
| ProFoam Wedge 50x25x12 | ProFoam Wedge 50x25x12 | FDA UDI | Class I | Active |
| CT Table Cover 2100 P | CT Table Cover 2100 P | FDA UDI | Class I | Active |
| PearlFit Cushion 50x20x4 Vac | PearlFit Cushion 50x20x4 Vac | FDA UDI | Class I | Active |
| FoamFit Plate 18x8x2 | FoamFit Plate 18x8x2 | FDA UDI | Class I | Active |
| PearlFit Wedge 30x50x15 | PearlFit Wedge 30x50x15 | FDA UDI | Class I | Active |
| CT HeadFix | CT HeadFix | FDA UDI | Class I | Active |
| pearltec | ProFoam Plate 100x25x1 DSR | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x60x3 DSG | FDA UDI | Class I | Active |
| PearlFit Cushion 50x50x5 | PearlFit Cushion 50x50x5 | FDA UDI | Class I | Active |
| PearlFit Vac Adapter | PearlFit Vac Adapter | FDA UDI | Class I | Active |
| ProFoam Wedge 18x25x7 | ProFoam Wedge 18x25x7 | FDA UDI | Class I | Active |
| FoamFit Plate 13x8x2 | FoamFit Plate 13x8x2 | FDA UDI | Class I | Active |
| ProBelt 350 R2 | ProBelt 350 R2 | FDA UDI | Class I | Active |
| PearlFit Head/Neck Tilt15 | PearlFit Head/Neck Tilt15 | FDA UDI | Class I | Active |
| PearlFit Head/Neck Vac | PearlFit Head/Neck Vac | FDA UDI | Class I | Active |
| PearlFit Cushion 30x20x4 Vac | PearlFit Cushion 30x20x4 Vac | FDA UDI | Class I | Active |
| CT Table Cover 2400 S | CT Table Cover 2400 S | FDA UDI | Class I | Active |
| CT Table Cover 2090 | CT Table Cover 2090 | FDA UDI | Class I | Active |
| PearlFit Cushion 130x60x5 Vac | PearlFit Cushion 130x60x5 Vac | FDA UDI | Class I | Active |
| ProFoam Wedge 18x23x10 30° DS | ProFoam Wedge 18x23x10 30° DS | FDA UDI | Class I | Active |
| BabyFix Cocoon | BabyFix Cocoon | FDA UDI | Class I | Active |
| PearlFit Wedge 26x25x7 | PearlFit Wedge 26x25x7 | FDA UDI | Class I | Active |
| Multipad Plus | Multipad Plus | FDA UDI | Class I | Active |
| PearlFit Head/Neck | PearlFit Head/Neck | FDA UDI | Class I | Active |
| ProBelt 350 R3 | ProBelt 350 R3 | FDA UDI | Class I | Active |
| ProFoam Wedge 50x25x12 DS | ProFoam Wedge 50x25x12 DS | FDA UDI | Class I | Active |
| PearlFit Cushion 50x30x5 Vac | PearlFit Cushion 50x30x5 Vac | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x70x3 DSGP | FDA UDI | Class I | Active |
| pearltec | BabyFix XL | FDA UDI | Class I | Active |
| CT Table Cover 310 | CT Table Cover 310 | FDA UDI | Class I | Active |
| ProFoam Plate 32x32x10 DS | ProFoam Plate 32x32x10 DS | FDA UDI | Class I | Active |
| ProFoam Plate 25x18x5 DS | ProFoam Plate 25x18x5 DS | FDA UDI | Class I | Active |
| pearltec | ProBelt 200 U5 | FDA UDI | Class I | Active |
| PearlFit Cushion 50x30x10 | PearlFit Cushion 50x30x10 | FDA UDI | Class I | Active |
| ProFoam Wedge 60x25x12 | ProFoam Wedge 60x25x12 | FDA UDI | Class I | Active |
| FoamFit Wedge 5x16x7 | FoamFit Wedge 5x16x7 | FDA UDI | Class I | Active |
| ProBelt 350 Extension | ProBelt 350 Extension | FDA UDI | Class I | Active |
| CT Table Cover 2400 S46 | CT Table Cover 2400 S46 | FDA UDI | Class I | Active |
| CT Table Cover 2170 G | CT Table Cover 2170 G | FDA UDI | Class I | Active |
| ProBelt 200 R2 | ProBelt 200 R2 | FDA UDI | Class I | Active |
| FoamFit Wedge 18x11x5 | FoamFit Wedge 18x11x5 | FDA UDI | Class I | Active |
| ProFoam Plate 25x18x5 | ProFoam Plate 25x18x5 | FDA UDI | Class I | Active |
| ProFoam Wedge 36x25x12 | ProFoam Wedge 36x25x12 | FDA UDI | Class I | Active |
| Multipad Slim | Multipad Slim | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x60x5 MFG | FDA UDI | Class I | Active |
| CT Table Cover 400 | CT Table Cover 400 | FDA UDI | Class I | Active |
| pearltec | Positioning KIT DXR Basic | FDA UDI | Class I | Active |
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