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Sign in to claim this brandBELLUS MEDICAL, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 207 Mockingbird Ln, Johnson City, TN, 37604
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010392991
- DUNS Number
- —
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SkinPen Precision Treatment Kits | 1 | FDA UDI | Class II | Unknown |
| ProGen PRP Eclipse | P5PG020 | FDA UDI | Class II | Unknown |
| SkinPen Precision Elite | REF200 | FDA UDI | Class II | Active |
| SkinPen Precision Elite | REF201 | FDA UDI | Class II | Active |
| SP MicroPen EVO | F5SP216 | FDA UDI | Class II | Active |
| SkinPen Precision Treatment Kit | F5SP013 | FDA UDI | Class II | Active |
| ProGen PRP Eclipse | P5PG052 | FDA UDI | Class II | Active |
| Progen PRP Eclipse | F5PG017 | FDA UDI | Class II | Active |
| Progen PRP Eclipse | F5PG019 | FDA UDI | Class II | Active |
| SkinPen Precision Elite | REF200/REF201 | FDA UDI | Class II | Active |
| Progen PRP Eclipse | TN15MLSINGLE | FDA UDI | Class II | Active |
| SkinPen Precision Treatment Kits | 1 | FDA UDI | Class II | Active |
| Progen PRP Eclipse | F5PG018 | FDA UDI | Class II | Active |
| Progen PRP Eclipse | TN30MLSINGLE | FDA UDI | Class II | Active |
| ProGen PRP Eclipse | P5PG019 | FDA UDI | Class II | Unknown |
| SkinPen Precision Treatment Kits | 1 | FDA UDI | Class II | Active |
| SkinPen Precision Premium Treatment Kit | F5SP391 | FDA UDI | Class II | Active |
| SkinPen Precision Charging Base | REF101 | FDA UDI | Class II | Active |
| SkinPen Precision Handpiece | REF100 | FDA UDI | Class II | Active |
| Progen PRP Eclipse | F5PG020 | FDA UDI | Class II | Active |
| ProGen PRP Eclipse | P5PG053 | FDA UDI | Class II | Active |
| SkinPen Precision Microneedling System | REF100/REF101 | FDA UDI | Class II | Active |
| SkinPen Precision System | DEN160029 | FDA 510(k) | Class II | 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 (1)
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 18, 2019 | Z-0660-2020 | — | terminated | Cosmetic Kit was packaged with a mislabel medical product. |