Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAlliedstar Medical Equipment Co., Ltd.
US
Last updated May 30, 2026
What Alliedstar Medical Equipment Co., Ltd. makes
Alliedstar Medical Equipment Co., Ltd. manufactures intraoral optical scanning systems designed for dental imaging, including models like NeoScan, Straumann SIRIOS X3, AlliedStar, and Alliedstar Sensa. These devices capture detailed 3D scans of oral structures to support digital dentistry workflows, such as crowns, bridges, and orthodontic treatments.
The company’s portfolio consists of Class II medical devices, which are regulated under the FDA’s Unique Device Identification (UDI) system. These devices are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer is based in the United States.
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 Alliedstar Medical Equipment Co., Ltd. primarily manufacture?
Alliedstar Medical Equipment Co., Ltd. specializes in intraoral optical scanning systems, such as the NeoScan, Straumann SIRIOS X3, AlliedStar, and Alliedstar Sensa. These devices are designed to create high-resolution 3D scans of a patient’s oral structures, enabling digital dentistry applications like crowns, bridges, and orthodontic planning.
Where is Alliedstar Medical Equipment Co., Ltd. based?
The company is headquartered in the United States. Its U.S. location aligns with regulatory requirements for manufacturing and distributing medical devices in North America.
Which regulatory registries or databases list Alliedstar Medical Equipment Co., Ltd.’s devices?
Alliedstar’s intraoral scanning systems are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, particularly for Class II devices.
How are Alliedstar Medical Equipment Co., Ltd.’s devices classified under U.S. regulations?
Alliedstar’s intraoral optical scanning systems fall under Class II classification in the U.S. This classification applies to devices with moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices are subject to premarket notification (510(k)) requirements or de novo pathways, depending on the specific device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 703541803
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeoScan | TP102N | EUDAMEDFDA UDI | Class II | Active |
| Straumann SIRIOS X3 | ST 300E | FDA UDI | Class II | Active |
| AlliedStar | AS 200E | FDA UDI | Class II | Active |
| Straumann SIRIOS X3 | ST 300E | EUDAMEDFDA UDI | Class II | Active |
| AlliedStar | TP202 | FDA UDI | Class II | Active |
| Straumann SIRIOS X3 | CHR 300E | EUDAMEDFDA UDI | Class II | Active |
| NeoScan | Handpiece Spare | EUDAMEDFDA UDI | Class II | Active |
| AlliedStar | AS 200E | FDA UDI | Class II | Active |
| Straumann Sirios | ST 200E Charging Holder | EUDAMEDFDA UDI | Class II | Active |
| Alliedstar Sensa | TP301 | FDA UDI | Class II | Active |
| AlliedStar | AS 260 Handpiece | FDA UDI | Class II | Active |
| NeoScan | Holder set | EUDAMEDFDA UDI | Class II | Active |
| Straumann SIRIOS X3 | ST 300E | EUDAMEDFDA UDI | Class II | Active |
| AlliedStar | TP203 | FDA UDI | Class II | Active |
| AlliedStar | AS 260 | FDA UDI | Class II | Active |
| Straumann SIRIOS X3 | TP311 | FDA UDI | Class II | Active |
| Straumann SIRIOS X3 | ST 300E | EUDAMEDFDA UDI | Class II | Active |
| Neoss | NeoScan 2000-Charging Holder | EUDAMEDFDA UDI | Class II | Active |
| Straumann SIRIOS X3 | ST 300E | EUDAMEDFDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.