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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 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gum® | 828 | FDA UDI | Class I | Active |
| Gum® | 2030 | FDA UDI | Class I | Active |
| Guidor | 5000 | FDA UDI | Class II | Unknown |
| Gum® | 4100 | FDA UDI | Class I | Active |
| GUM Technique Sensitive Clean | 527 | FDA UDI | Class I | Active |
| Gum® | 614 | FDA UDI | Class I | Active |
| Gum® | 461 | FDA UDI | Class I | Active |
| Gum® | 887 | FDA UDI | Class I | Active |
| Gum® | 1312 | FDA UDI | Class I | Active |
| Gum® | 828 | FDA UDI | Class I | Active |
| Gum® | 889 | FDA UDI | Class I | Active |
| Gum® | 821 | FDA UDI | Class I | Active |
| Guidor | C11-078 | FDA UDI | Class II | Unknown |
| Gum® | KIT59 | FDA UDI | Class I | Active |
| Gum® | 893 | FDA UDI | Class I | Active |
| GUM Barbie Power Toothbrush | 90196 | FDA UDI | Class I | Active |
| Gum® | 1618 | FDA UDI | Class I | Active |
| Gum® | 1840 | FDA UDI | Class I | Active |
| Gum® | 3615 | FDA UDI | Class I | Active |
| Gum® | 515 | FDA UDI | Class I | Active |
| Gum® | 460 | FDA UDI | Class I | Active |
| Gum® | 877 | FDA UDI | Class I | Active |
| Gum® | 887 | FDA UDI | Class I | Active |
| Gum® | 158 | FDA UDI | Class I | Active |
| Gum® | 3612 | FDA UDI | Class I | Active |
| Gum® | 90199 | FDA UDI | Class I | Active |
| Gum® | 3612 | FDA UDI | Class I | Active |
| Gum® | 888 | FDA UDI | Class I | Active |
| Gum® | 3614 | FDA UDI | Class I | Active |
| Gum® | 2030 | FDA UDI | Class I | Active |
| Gum® | 2030 | FDA UDI | Class I | Active |
| Gum® | 228 | FDA UDI | Class I | Active |
| Gum® | 4100 | FDA UDI | Class I | Active |
| Gum® | KIT234 | FDA UDI | Class I | Active |
| Gum® | 157 | FDA UDI | Class I | Active |
| Guidor | 5060 | FDA UDI | Class II | Unknown |
| Gum® | KIT505 | FDA UDI | Class I | Active |
| Gum® | 892 | FDA UDI | Class I | Active |
| Gum® | 2010 | FDA UDI | Class I | Active |
| Gum® | 897 | FDA UDI | Class I | Active |
| Gum® | 614 | FDA UDI | Class I | Active |
| Gum® | 90033 | FDA UDI | Class I | Active |
| Gum® | 859 | FDA UDI | Class I | Active |
| Gum® | 828 | FDA UDI | Class I | Active |
| Gum® | KIT34 | FDA UDI | Class I | Active |
| Gum® | 872 | FDA UDI | Class I | Active |
| Gum® | 99184 | FDA UDI | Class I | Active |
| Gum® | 414 | FDA UDI | Class I | Active |
| Gum® | 874 | FDA UDI | Class I | Active |
| Gum® | 857 | 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 |