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Sign in to claim this brandGentell
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 180 Rittenhouse Circle, Bristol, PA, 19007
- Website
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000522686
- DUNS Number
- —
Catalogue (54)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gentell | GEN-13060 | FDA UDI | Class I | Active |
| Dermatell Hydrocolloid Sacral Dressing (6x7 in) | GEN-11100 | FDA UDI | Class I | Active |
| Dermatell Hydrocolloid (Non-Bordered) Wound Dressing (4x4 in) | GEN-10100 | FDA UDI | Class I | Active |
| Gentell Hydrogel Sheet Dressing | GEN-11240 | FDA UDI | Class I | Active |
| Gentell | GEN-11700 | FDA UDI | Class I | Unknown |
| Gentell | GEN-15616 | FDA UDI | Class I | Active |
| Super Absorbent Dressing (2x2 in) | GEN-19320 | FDA UDI | Class I | Active |
| Calcium Alginate Dressing (4x8 in) | GEN-13480 | FDA UDI | Class I | Active |
| Gentell | GEN-18400 | FDA UDI | U | Active |
| Gentell | GEN-11240 | FDA UDI | Class I | Unknown |
| Dermatell Hydrocolloid (Bordered) Wound Dressing (6x6 in) | GEN-10400 | FDA UDI | Class I | Active |
| Gentell | GEN-11470 | FDA UDI | Class I | Unknown |
| Oil Emulsion Dressing (3 x 3 in) | GEN-19000 | FDA UDI | Class I | Active |
| Calcium Alginate Ag Dressing 6"x6" | GEN-13620 | FDA UDI | U | Active |
| Gentell | GEN-13066 | FDA UDI | U | Active |
| Gentell | GEN-13022 | FDA UDI | U | Active |
| Gentell | GEN-11541 | FDA UDI | U | Active |
| Super Absorbent Adherent Dressing (8x8 in) | GEN-19480 | FDA UDI | Class I | Active |
| Calcium Alginate Dressing (10x10 in) | GEN-13010 | FDA UDI | Class I | Active |
| Calcium Alginate Ag (Silver) Dressing (2x2 in) | GEN-13220 | FDA UDI | U | Active |
| Gentell | GEN-13020 | FDA UDI | Class I | Active |
| Super Absorbent Adherent Dressing (5x5 in) | GEN-19450 | FDA UDI | Class I | Active |
| Gentell | GEN-15414 | FDA UDI | Class I | Active |
| Gentell | GEN-18700 | FDA UDI | U | Active |
| Super Absorbent Adherent Dressing 6" x 6" | GEN-19460 | FDA UDI | Class I | Active |
| Comfortell Composite Dressing (4x4 in | GEN-12400 | FDA UDI | Class I | Active |
| Petrolatum Gauze (3x9 in) | GEN-19100 | FDA UDI | Class I | Active |
| Calcium Alginate Dressing (6x6 in) | GEN-13700 | FDA UDI | Class I | Active |
| Gentell | GEN-13040 | FDA UDI | Class I | Active |
| Calcium Alginate Ag (Silver) Dressing (4x8 in) | GEN-13482 | FDA UDI | U | Active |
| Super Absorbent Adherent Dressing (2x2 in) | GEN-19420 | FDA UDI | Class I | Active |
| Gentell | GEN-11751 | FDA UDI | U | Active |
| Dermatell Hydrocolloid (Bordered) Wound Dressing (4x4 in) | GEN-10200 | FDA UDI | Class I | Active |
| Super Absorbent Dressing (4x4 in) | GEN-19340 | FDA UDI | Class I | Active |
| Calcium Alginate Dressing (2x2 in) | GEN-13200 | FDA UDI | Class I | Active |
| Comfortell Composite Dressing (6x6 in) | GEN-12600 | FDA UDI | Class I | Active |
| Gentell FixTape (2x11 yards) | GEN-10600 | FDA UDI | Class I | Active |
| Calcium Alginate Ag (Silver) Dressing Rope (12 in) | GEN-13142 | FDA UDI | U | Active |
| Gentell | GEN-18000 | FDA UDI | U | Active |
| Gentell | GEN-18200 | FDA UDI | U | Active |
| Gentell | GEN-13044 | FDA UDI | U | Active |
| Calcium Alginate Dressing Rope (12 in) | GEN-13120 | FDA UDI | Class I | Active |
| Gentell | GEN-11221 | FDA UDI | U | Active |
| Gentell | GEN-15818 | FDA UDI | Class I | Active |
| Gentell FixTape (4x11 yards) | GEN-10640 | FDA UDI | Class I | Active |
| Circular Split Drain Foam Dressing (4 in) Diameter | GEN-14410 | FDA UDI | Class I | Active |
| Gentell Hydrogel Sheet Dressing | GEN-11470 | FDA UDI | Class I | Active |
| Calcium Alginate Dressing (4x4 in) | GEN-13500 | FDA UDI | Class I | Active |
| Super Absorbent Dressing 6" x 6" | GEN-19360 | FDA UDI | Class I | Active |
| Calcium Alginate Ag (Silver) Dressing (8x8 in) | GEN-13820 | FDA UDI | U | Active |
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FDA Recalls (8)
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 |
|---|---|---|---|---|
| Mar 26, 2020 | Z-1910-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Mar 26, 2020 | Z-1908-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Mar 26, 2020 | Z-1907-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Mar 26, 2020 | Z-1909-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Feb 27, 2020 | Z-1624-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Feb 27, 2020 | Z-1625-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Feb 27, 2020 | Z-1626-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Feb 27, 2020 | Z-1623-2020 | — | open, classified | During an FDA audit, it was discovered that the product was not properly registered with FDA. |