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Sign in to claim this brandPARKELL, INC.
United States·US-MF-000003761
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 300, Executive Drive, Edgewood, United States
- Website
- www.parkell.com
- —
- —
- [email protected]
- Phone
- 6312491134
- PRRC Contact
- Yasily Ogando
- EUDAMED SRN
- US-MF-000003761
- FDA FEI Number
- 2411797
- DUNS Number
- 009900424
Catalogue (798)
Page 5 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MucoHard™ | S485 | FDA UDI | Class II | Unknown |
| Epic® | S364 | FDA UDI | Class II | Unknown |
| Sensimatic™ | D700SE110 | FDA UDI | Class II | Unknown |
| SEcure® | S271 | FDA UDI | Class II | Unknown |
| Epic® | S362UD | FDA UDI | Class II | Active |
| Sensimatic® | D601-K | FDA UDI | Class II | Unknown |
| Epic® | S356 | FDA UDI | Class II | Unknown |
| TurboVue™ | D570230 | FDA UDI | Class II | Unknown |
| Epic® | S314UD | FDA UDI | Class II | Unknown |
| Sensimatic™ | D700SE10CR | FDA UDI | Class II | Unknown |
| Parkell® | SD770-8 | FDA UDI | Class I | Unknown |
| Snap™ | S450 | FDA UDI | Class II | Unknown |
| SmarTemp® | S347 | FDA UDI | Class II | Active |
| Parkell® | SD038-035 | FDA UDI | Class I | Unknown |
| MucoHard™ | S641 | FDA UDI | Class II | Active |
| Epic® | S368 | FDA UDI | Class II | Active |
| Burnett Power-Tip™ | DTI25 | FDA UDI | Class II | Unknown |
| Integra™ | D680110 | FDA UDI | Class II | Unknown |
| Brush&Bond® | S287 | FDA UDI | Class II | Unknown |
| C.i.™ | S120 | FDA UDI | Class I | Active |
| Foramatron® | D645 | FDA UDI | U | Unknown |
| Epic® | S356 | FDA UDI | Class II | Active |
| Blu-Mousse® | S437S | FDA UDI | Class II | Unknown |
| Blu-Mousse® | S440S | FDA UDI | Class II | Unknown |
| Foramatron® | D613 | FDA UDI | U | Active |
| SEcure® | S270 | FDA UDI | Class II | Active |
| Snap™ | S451 | FDA UDI | Class II | Active |
| Foramatron® | D611 | FDA UDI | U | Unknown |
| Expandex™ | S228 | FDA UDI | Class I | Unknown |
| Parkell® | DSG30UP | FDA UDI | Class II | Unknown |
| Blu-Mousse® | S438-K | FDA UDI | Class II | Unknown |
| Parkell® | SD862-012 | FDA UDI | Class I | Unknown |
| Brush&Bond® | S284 | FDA UDI | Class II | Active |
| TurboVue™ | D570110 | FDA UDI | Class II | Unknown |
| Parkell® | SDS-856-016C | FDA UDI | Class I | Active |
| Foramatron® | D645CR | FDA UDI | U | Unknown |
| TurboVue™ | DLH30P | FDA UDI | Class II | Unknown |
| Parkell® | SDS-860-012F | FDA UDI | Class I | Unknown |
| Integra™ | D680-230 | FDA UDI | Class II | Unknown |
| Parkell® | Type-G | FDA UDI | Class II | Active |
| C.i.™ | S119 | FDA UDI | Class I | Active |
| Sensimatic™ | D601 | FDA UDI | Class II | Unknown |
| Amalgambond® | S376 | FDA UDI | Class II | Active |
| Parkell® | S150L | FDA UDI | Class I | Unknown |
| Parkell® | D418 | FDA UDI | Class II | Active |
| Parkell® | S244 | FDA UDI | Class II | Unknown |
| Parkell® | S196A | FDA UDI | Class I | Unknown |
| Snap™ | S427 | FDA UDI | Class II | Unknown |
| Snap™ | S479 | FDA UDI | Class II | Active |
| Parkell® | T-05 | FDA UDI | Class II | Active |
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Authorised Representatives
- Directa AB SE
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