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Sign in to claim this brandHuliang(Shanghai) Biotech Co., Ltd.
US
Last updated September 17, 2026
What Huliang(Shanghai) Biotech Co., Ltd. makes
The company produces reusable mouthguards, preformed complete dentures, and temporary dental crowns or bridges, primarily using PMMA (polymethyl methacrylate) blocks as the base material. These devices are designed for dental applications, including protective oral gear and restorative solutions for patients.
The portfolio includes devices classified as Class II and Unclassified (U) under regulatory frameworks, with listings in the FDA’s Unique Device Identifier (UDI) database. The company operates with a presence 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 Huliang(Shanghai) Biotech Co., Ltd. manufacture?
Huliang(Shanghai) Biotech Co., Ltd. specializes in dental devices, including reusable mouthguards, preformed complete dentures, and temporary dental crowns or bridges. These products are designed to provide protective oral gear and restorative solutions for patients, primarily using PMMA (polymethyl methacrylate) blocks as the foundational material.
Where is Huliang(Shanghai) Biotech Co., Ltd. based, and does it operate in the United States?
Huliang(Shanghai) Biotech Co., Ltd. has a presence in the United States, though its headquarters are based in Shanghai, China. The company’s devices listed in the FDA’s Unique Device Identifier (UDI) database reflect its regulatory engagement in the U.S. market.
Which regulatory registries list Huliang(Shanghai) Biotech Co., Ltd.’s devices?
Huliang(Shanghai) Biotech Co., Ltd.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers.
How are Huliang(Shanghai) Biotech Co., Ltd.’s devices classified under regulatory frameworks?
Huliang(Shanghai) Biotech Co., Ltd.’s devices fall under two primary classifications: Class II and Unclassified (U). Class II devices typically pose moderate risks and require special controls to ensure safety and effectiveness, while Unclassified devices may not yet have a formal classification assigned but are still subject to regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 412706288
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pmma Block | Shade: B1; Spec:98*10mm; Net Weight:87g | FDA UDI | Class II | Active |
| Pmma Block | Shade:Clear; Spec:98*20mm; Net Weight:175g | FDA UDI | U | Active |
| Pmma Block | Shade: BL; Spec:98*10mm; Net Weight:87g | FDA UDI | Class II | Active |
| Pmma Block | Shade: A4; Spec:98*10mm; Net Weight:87g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML B2; Spec:98*20mm; Net Weight:175g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML A2; Spec:98*16mm; Net Weight:140g | FDA UDI | Class II | Active |
| Pmma Block | Shade: C2; Spec:98*10mm; Net Weight:87g | FDA UDI | U | Active |
| Pmma Block | Shade: C1; Spec:98*10mm; Net Weight:87g | FDA UDI | U | Active |
| Pmma Block | Shade:ML C1; Spec:98*25mm; Net Weight:210g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML C1; Spec:98*20mm; Net Weight:175g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML A3; Spec:98*16mm; Net Weight:140g | FDA UDI | Class II | Active |
| Pmma Block | Shade:A2; Spec:98*25mm; Net Weight:210g | FDA UDI | Class II | Active |
| Pmma Block | Shade:B1; Spec:98*25mm; Net Weight:210g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML C2; Spec:98*25mm; Net Weight:210g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML B2; Spec:98*25mm; Net Weight:210g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML A2; Spec:98*25mm; Net Weight:210g | FDA UDI | Class II | Active |
| Pmma Block | Shade: B2; Spec:98*10mm; Net Weight:87g | FDA UDI | Class II | Active |
| Pmma Block | Shade:ML B2; Spec:98*16mm; Net Weight:140g | FDA UDI | U | Active |
| Pmma Block | Shade:ML C2; Spec:98*16mm; Net Weight:140g | FDA UDI | U | Active |
| Pmma Block | Shade:ML A1; Spec:98*16mm; Net Weight:140g | FDA UDI | Class II | Active |
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