Is this your brand? Sign in to claim ownership.
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 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| pearltec | Sandbag 40x20, 3 kg | FDA UDI | Class I | Active |
| pearltec | Neuro Kit | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x60x3 DSRG | FDA UDI | Class I | Active |
| ProBelt 200 Thorax PFW | ProBelt 200 Thorax PFW | FDA UDI | Class I | Active |
| FoamFit Plate 36x8x2 | FoamFit Plate 36x8x2 | FDA UDI | Class I | Active |
| PearlFit Wedge 30x50x15 Vac | PearlFit Wedge 30x50x15 Vac | FDA UDI | Class I | Active |
| PearlFit Wedge 56x50x25 Vac | PearlFit Wedge 56x50x25 Vac | FDA UDI | Class I | Active |
| PearlFit Cushion 30x11x2 | PearlFit Cushion 30x11x2 | FDA UDI | Class I | Active |
| PearlFit Cushion 200x75x7 Vac | PearlFit Cushion 200x75x7 Vac | FDA UDI | Class I | Active |
| pearltec | Sandbag 24x18, 1.25 kg | FDA UDI | Class I | Active |
| PearlFit Cushion 50x30x10 Vac | PearlFit Cushion 50x30x10 Vac | FDA UDI | Class I | Active |
| ProBelt 140 MRI P | ProBelt 140 MRI P | FDA UDI | Class I | Active |
| PearlFit Cushion 50x30x7 Vac | PearlFit Cushion 50x30x7 Vac | FDA UDI | Class I | Active |
| ProFoam Wedge 18x23x10 30° | ProFoam Wedge 18x23x10 30° | FDA UDI | Class I | Active |
| CT Table Cover 2580 P44 | CT Table Cover 2580 P44 | FDA UDI | Class I | Active |
| CT Table Cover 2100 G | CT Table Cover 2100 G | FDA UDI | Class I | Active |
| ProBelt 50 VL C Kit | ProBelt 50 VL C Kit | FDA UDI | Class I | Active |
| ProBelt 200 J10 | ProBelt 200 J10 | FDA UDI | Class I | Active |
| PearlFit Cushion MAQSIE Vac | PearlFit Cushion MAQSIE Vac | FDA UDI | Class I | Active |
| pearltec | ProFoam Head Support | FDA UDI | Class I | Active |
| CT Table Cover 2320 P44 | CT Table Cover 2320 P44 | FDA UDI | Class I | Active |
| ProBelt 50VH Kit | ProBelt 50VH Kit | FDA UDI | Class I | Active |
| PearlFit Cushion 22x8x1 | PearlFit Cushion 22x8x1 | FDA UDI | Class I | Active |
| FoamFit Plate 28x18x1 | FoamFit Plate 28x18x1 | FDA UDI | Class I | Active |
| CT Table Cover 350 S | CT Table Cover 350 S | FDA UDI | Class I | Active |
| PearlFit Cushion 200x75x7 | PearlFit Cushion 200x75x7 | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x60x5 MFGP | FDA UDI | Class I | Active |
| pearltec | ProFoam Table Mat 200x70x3 DSRG | FDA UDI | Class I | Active |
| PearlFit Wedge 26x25x7 Vac | PearlFit Wedge 26x25x7 Vac | FDA UDI | Class I | Active |
| ProFoam Plate 50x30x20 DS | ProFoam Plate 50x30x20 DS | FDA UDI | Class I | Active |
| ProBelt 70 Wrap | ProBelt 70 Wrap | FDA UDI | Class I | Active |
| CT Table Cover 2360 | CT Table Cover 2360 | FDA UDI | Class I | Active |
| PearlFit Roll 40 | PearlFit Roll 40 | FDA UDI | Class I | Active |
| PearlFit Cushion 90x60x5 Vac | PearlFit Cushion 90x60x5 Vac | FDA UDI | Class I | Active |
| ProBelt 200 Wrap | ProBelt 200 Wrap | FDA UDI | Class I | Active |
| PearlFit Wedge 56x50x25 | PearlFit Wedge 56x50x25 | FDA UDI | Class I | Active |
| Multipad Ear | Multipad Ear | FDA UDI | Class I | Active |
| pearltec | Positioning KIT HP Advanced | FDA UDI | Class I | Active |
| CT Table Cover 2190 S | CT Table Cover 2190 S | FDA UDI | Class I | Active |
| ProBelt 140 MRI P Extension | ProBelt 140 MRI P Extension | FDA UDI | Class I | Active |
| pearltec | ProFoam Plate 50x25x1 DSR | FDA UDI | Class I | Active |
| PearlFit Forehead | PearlFit Forehead | FDA UDI | Class I | Active |
| ProBelt 350 T5 | ProBelt 350 T5 | FDA UDI | Class I | Active |
| CT Table Cover 2580 G | CT Table Cover 2580 G | FDA UDI | Class I | Active |
| CT Table Cover 1790 | CT Table Cover 1790 | FDA UDI | Class I | Active |
| CT Table Cover 370 G | CT Table Cover 370 G | FDA UDI | Class I | Active |
| ProBelt 350 J10 | ProBelt 350 J10 | FDA UDI | Class I | Active |
| ProBelt 50 VL C | ProBelt 50 VL C | FDA UDI | Class I | Active |
| FoamFit Wedge 36x11x5 | FoamFit Wedge 36x11x5 | FDA UDI | Class I | Active |
| ProBelt 200 R3 | ProBelt 200 R3 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.