Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAmtai Medical Equipment, Inc.
US
Last updated September 17, 2026
What Amtai Medical Equipment, Inc. makes
Amtai Medical Equipment, Inc. manufactures electrohydraulic universal operating tables and operating room light systems, including standalone operating room lights. These products are designed for surgical environments to provide adjustable positioning and high-intensity illumination for procedures.
The company’s devices are classified as Class I and Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is regulated 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 Amtai Medical Equipment, Inc. manufacture?
Amtai Medical Equipment, Inc. specializes in surgical equipment for operating rooms. Their primary products include electrohydraulic universal operating tables, which allow precise patient positioning, and operating room light systems. These systems can also include standalone operating room lights designed to provide high-intensity illumination tailored for surgical procedures.
Where is Amtai Medical Equipment, Inc. based, and where are their devices regulated?
Amtai Medical Equipment, Inc. is based in the United States. Their devices are regulated under U.S. FDA guidelines, with classification under Class I and Class II categories, indicating varying levels of risk and regulatory oversight.
Which regulatory registries or databases list Amtai Medical Equipment, Inc.’s devices?
Amtai Medical Equipment, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability.
How are Amtai Medical Equipment, Inc.’s devices classified under FDA regulations?
Amtai Medical Equipment, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may be exempt from some regulatory controls, while Class II devices require stricter oversight due to moderate risk. Classification depends on factors like the device’s purpose, intended use, and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 5605 PRIMAVERA CT, Raleigh, NC, 27616
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007591382
- DUNS Number
- —
Catalogue (144)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amtai | LS2-CD-1 | FDA UDI | Class II | Active |
| Amtai | ACC0013 | FDA UDI | Class I | Active |
| Amtai | ACC0051 | FDA UDI | Class I | Active |
| Amtai | ACC0084-4 | FDA UDI | Class I | Active |
| Amtai | LS2-BD-1 | FDA UDI | Class II | Active |
| Amtai | LL2-BD-2 | FDA UDI | Class II | Active |
| Amtai | ACC0034 | FDA UDI | Class I | Active |
| Amtai | T1000K.1v03.1 | FDA UDI | Class I | Active |
| Amtai | LS2-CB-1(I) | FDA UDI | Class II | Active |
| Amtai | LS3-BBD-1 | FDA UDI | Class II | Active |
| Amtai | LM-D-1 | FDA UDI | Class II | Active |
| Amtai | ACC0061 | FDA UDI | Class I | Active |
| Amtai | LS4-BDDA-1 | FDA UDI | Class II | Active |
| Amtai | ACC0021 | FDA UDI | Class I | Active |
| Amtai | LS2-BB-1(I) | FDA UDI | Class II | Active |
| Amtai | ACC0084-2 | FDA UDI | Class I | Active |
| Amtai | LS4-CDAA-2 (I) | FDA UDI | Class II | Active |
| Amtai | ACC0071 | FDA UDI | Class I | Active |
| Amtai | CP001291 | FDA UDI | Class I | Active |
| Amtai | ACC0026 | FDA UDI | Class I | Active |
| Amtai | LS3-CDA-1 | FDA UDI | Class II | Active |
| Amtai | LS3-BDA-1 | FDA UDI | Class II | Active |
| Amtai | LS1-D-2 | FDA UDI | Class II | Active |
| Amtai | ACC0025 | FDA UDI | Class I | Active |
| Amtai | ACC0017-1 | FDA UDI | Class I | Active |
| Amtai | ACC0116 | FDA UDI | Class I | Active |
| Amtai | ACC0015 | FDA UDI | Class I | Active |
| Amtai | LS1-B-1 | FDA UDI | Class II | Active |
| Amtai | ACC0043 | FDA UDI | Class I | Active |
| Amtai | ACC0047-1 | FDA UDI | Class I | Active |
| Amtai | LS1-C-1(I) | FDA UDI | Class II | Active |
| Amtai | ACC0049v01 | FDA UDI | Class I | Active |
| Amtai | ASM0124 | FDA UDI | Class I | Active |
| Amtai | ACC0029 | FDA UDI | Class I | Active |
| Amtai | LS3-CDD-1(I) | FDA UDI | Class II | Active |
| Amtai | LS4-CBAA-1 | FDA UDI | Class II | Active |
| Amtai | ACC0063 | FDA UDI | Class I | Active |
| Amtai | ACC0037 | FDA UDI | Class I | Active |
| Amtai | LM-D-1(I) | FDA UDI | Class II | Active |
| Amtai | ACC0046-1 | FDA UDI | Class I | Active |
| Amtai | ACC0046-2 | FDA UDI | Class I | Active |
| Amtai | ACC0010 | FDA UDI | Class I | Active |
| Amtai | CP001521v00.1 | FDA UDI | Class I | Active |
| Amtai | CP002459 | FDA UDI | Class I | Active |
| Amtai | LS4-BBAA-1(I) | FDA UDI | Class II | Active |
| Amtai | LS4-BBDA-1 | FDA UDI | Class II | Active |
| Amtai | ACC0019 | FDA UDI | Class I | Active |
| Amtai | ACC0016 | FDA UDI | Class I | Active |
| Amtai | ACC0108 | FDA UDI | Class I | Active |
| Amtai | LS3-BDA-1(I) | FDA 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.