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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 225 Cedar Hill Street, Marlborough, MA, 01752
- Website
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- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3020221089
- DUNS Number
- —
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Thuvera | MD2300F-001638 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-001780 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-002247 | FDA UDI | Class II | Active |
| Thuvera | MD2100F-001632H | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001650 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-002244 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001635 | FDA UDI | Class II | Active |
| Thuvera | MD2100F-001632 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-001518 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-001780 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001952 | FDA UDI | Class II | Active |
| Thuvera | MD2100F-001632R | FDA UDI | Class II | Active |
| Regenalase | MD2300F-002245 | FDA UDI | Class II | Active |
| Thuvera | MD2100F-001632D | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001651 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-002246 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-001534 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001960 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001649 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001647 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001633 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001639 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001648 | FDA UDI | Class II | Active |
| Regenalase | MD2300F-001754 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001636 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001634 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001507 | FDA UDI | Class II | Active |
| Thuvera | MD2300F-001637 | FDA UDI | Class II | Active |
| Ipgtfl-02 | K251100 | FDA 510(k) | Class II | Active |
| IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories | K232568 | FDA 510(k) | Class II | Active |
| Regenalase Laser System | K233344 | FDA 510(k) | Class II | Active |
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