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Sign in to claim this brandSUNSTAR AMERICAS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 301 East Central Road, Schaumburg, IL, 60195
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1413787
- DUNS Number
- —
Catalogue (180)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gum® | 124 | FDA UDI | Class I | Active |
| Gum® | 885 | FDA UDI | Class I | Active |
| Guidor | C11-018 | FDA UDI | Class II | Unknown |
| Gum® | 153 | FDA UDI | Class I | Active |
| Gum | 90291 | FDA UDI | Class I | Active |
| Gum® | 2202 | FDA UDI | Class I | Active |
| Gum® | 4100 | FDA UDI | Class I | Active |
| Gum® | 3614 | FDA UDI | Class I | Active |
| Gum® | 9940 | FDA UDI | Class I | Active |
| Gum® | 153 | FDA UDI | Class I | Active |
| Gum® | 612 | FDA UDI | Class I | Active |
| Gum® | 888 | FDA UDI | Class I | Active |
| Butler® | 1219 | FDA UDI | Class II | Unknown |
| Gum® | 828 | FDA UDI | Class I | Active |
| Gum® | KIT461 | FDA UDI | Class I | Active |
| Gum® | 2008 | FDA UDI | Class I | Active |
| Gum® | 3614 | FDA UDI | Class I | Active |
| Gum® | 1916 | FDA UDI | Class I | Active |
| Gum® | 3615 | FDA UDI | Class I | Active |
| Gum® | 800 | FDA UDI | Class I | Unknown |
| Gum® | 3615 | FDA UDI | Class I | Unknown |
| Gum® | 2030 | FDA UDI | Class I | Active |
| Gum® | 828 | FDA UDI | Class I | Active |
| Gum® | 618 | FDA UDI | Class I | Active |
| Gum® | 885 | FDA UDI | Class I | Active |
| Gum® | 1812 | FDA UDI | Class I | Active |
| Gum® | 125 | FDA UDI | Class I | Active |
| GUM Technique Sensitive Clean | 524TPA1 | FDA UDI | Class I | Active |
| Gum® | 614 | FDA UDI | Class I | Active |
| Gum® | 828 | FDA UDI | Class I | Active |
| Gum® | 3614 | FDA UDI | Class I | Active |
| Gum® | 840 | FDA UDI | Class I | Active |
| Gum® | 471 | FDA UDI | Class I | Active |
| Gum® | 2006 | FDA UDI | Class I | Active |
| Guidor | 5020 | FDA UDI | Class II | Unknown |
| Gum® | 871 | FDA UDI | Class I | Active |
| Gum® | 874 | FDA UDI | Class I | Active |
| Gum | KIT56 | FDA UDI | Class I | Active |
| Gum® | 896 | FDA UDI | Class I | Active |
| Guidor | 5081 | FDA UDI | Class II | Unknown |
| Gum® | KIT33 | FDA UDI | Class I | Active |
| Gum® | 840 | FDA UDI | Class I | Active |
| Gum® | 4110 | FDA UDI | Class I | Active |
| Gum® | 871 | FDA UDI | Class I | Active |
| Gum® | 1614 | FDA UDI | Class I | Active |
| Gum® | 1840 | FDA UDI | Class I | Active |
| GUM Mixed Mini Wing | 90198 | FDA UDI | Class I | Active |
| Gum® | KIT135 | FDA UDI | Class I | Active |
| Gum® | 2272 | FDA UDI | Class I | Active |
| Gum® | 9934 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 14, 2022 | Z-0720-2022 | — | terminated | Product lacks premarket clearance. |
| May 21, 2021 | Z-1837-2021 | — | terminated | Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. |
| Mar 23, 2021 | Z-1382-2021 | — | terminated | Product may be contaminated with Burkholderia contaminans. |
| Feb 18, 2021 | Z-1182-2021 | — | terminated | The product may be contaminated with Burkholderia cepacia |