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US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 276075371
Catalogue (559)
Page 10 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EdgeOne-R Utopia | Asst L25 Sterile | FDA UDI | Class I | Active |
| Engine Reamers | n010 L21 | FDA UDI | Class I | Active |
| Hedstroem files | n008 L25 | FDA UDI | Class I | Active |
| Pastinject | n25 L21 | FDA UDI | Class I | Active |
| Revo-S | SC2 L29 | FDA UDI | Class I | Active |
| Pastinject | n35 L25 | FDA UDI | Class I | Active |
| Engine Reamers | n025 L21 | FDA UDI | Class I | Active |
| Rispi Sonic | n6 L19 | FDA UDI | Class I | Active |
| H-Files | N055 L25 | FDA UDI | Class I | Active |
| H-Files | N110 L21 | FDA UDI | Class I | Active |
| K-Reamers | N006 L31 | FDA UDI | Class I | Active |
| K-Files | N015 L25 | FDA UDI | Class I | Active |
| Shaper | n15 L21 ISO M10 | FDA UDI | Class I | Active |
| Giro-Files | n040 L25 ISO M07 | FDA UDI | Class I | Active |
| H-Files | N130 L21 | FDA UDI | Class I | Active |
| G-Files | G1 n12 L25 3% | FDA UDI | Class I | Active |
| K Files | n006 L25 | FDA UDI | Class I | Active |
| Endoflare | n25 12% L15 | FDA UDI | Class I | Active |
| H-Files | N008/015 L21 | FDA UDI | Class I | Active |
| H-Files | N015 L31 | FDA UDI | Class I | Active |
| MicroMega One RECI | N35 4% L25 STERILE | FDA UDI | Class I | Active |
| H-Files | N030 L21 | FDA UDI | Class I | Active |
| H-Files | N055 L31 | FDA UDI | Class I | Active |
| H-Files | N050 L31 | FDA UDI | Class I | Active |
| Girofiles | n008 L21 | FDA UDI | Class I | Active |
| Spiral Fillers | n50 L25 | FDA UDI | Class I | Active |
| Shaper | n25 L21 | FDA UDI | Class I | Active |
| K-Reamers | N006 L21 | FDA UDI | Class I | Active |
| Rispi Sonic | n2 L19 | FDA UDI | Class I | Active |
| MicroMega One RECI | N25 4% L31 STERILE | FDA UDI | Class I | Active |
| Evo Flex | N14 3% L25 Sterile | FDA UDI | Class I | Active |
| H-Files | N020 L21 | FDA UDI | Class I | Active |
| 2Shape Mini | TS2 n25 6% L25 Classics sterile | FDA UDI | Class I | Active |
| EdgeTaper Blaze Utopia | Asst L21 Sterile | FDA UDI | Class I | Active |
| K-Files | N008/015 L21 | FDA UDI | Class I | Active |
| MicroMega One RECI | N45 4% L31 STERILE | FDA UDI | Class I | Active |
| K-Files | N070 L25 | FDA UDI | Class I | Active |
| H-Files | N045 L25 | FDA UDI | Class I | Active |
| One Curve | n45 4% L25 | FDA UDI | Class I | Active |
| K-Reamers | N090 L31 | FDA UDI | Class I | Active |
| One Curve Starter Pack | L31 | FDA UDI | Class I | Active |
| K-Reamers | N025 L21 | FDA UDI | Class I | Active |
| K-Files | N100 L31 | FDA UDI | Class I | Active |
| K-Files | N090 L21 | FDA UDI | Class I | Active |
| K-Reamers | N045 L21 | FDA UDI | Class I | Active |
| MicroMega One RECI | N25 6% L25 STERILE | FDA UDI | Class I | Active |
| One Curve | n25 4% L21 | FDA UDI | Class I | Active |
| K-Files | N030 L25 | FDA UDI | Class I | Active |
| H-Files | N025 L21 | FDA UDI | Class I | Active |
| One Shape Apical | ONE SHAPE APICAL1 n030 6% L21 Classics sterile | FDA UDI | Class I | Active |
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