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PARKELL, 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 6312491134
PRRC Contact: Yasily Ogando
EUDAMED SRN: US-MF-000003761
FDA FEI Number: 2411797
DUNS Number: 009900424

Catalogue (798)

Page 15 of 16

Device	Model / Reference	Registries	Class	Status
Parkell®	S439IOT	EUDAMEDFDA UDI	Class I	Active
Parkell®	S431	EUDAMEDFDA UDI	Class I	Active
Predicta™	S601	EUDAMEDFDA UDI	Class IIa	Active
Cinch®	S460S	EUDAMEDFDA UDI	Class I	Active
Parkell®	S275	EUDAMEDFDA UDI	Class I	Active
Parkell®	DUI30	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S189	EUDAMEDFDA UDI	Class I	Active
Predicta™	S616	EUDAMEDFDA UDI	Class IIa	Active
Comfort Grip™	DCG30Tri	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S540	EUDAMED	Class I	Active
Parkell®	DSG30U	EUDAMEDFDA UDI	Class IIa	Active
Predicta®	S632	EUDAMEDFDA UDI	Class IIa	Active
Hyperfil®	S323	EUDAMEDFDA UDI	Class IIa	Active
Hedgehog™	S500	EUDAMEDFDA UDI	Class I	Active
Parkell®	S302	EUDAMEDFDA UDI	Class I	Active
AccuFilm II	S017	EUDAMEDFDA UDI	Class I	Active
Burnett Power-Tip™	DTI30	EUDAMEDFDA UDI	Class IIa	Active
Accu-Film®	S054	EUDAMEDFDA UDI	Class I	Active
Parkell®	S633	EUDAMEDFDA UDI	Class I	Active
Parkell®	S445	EUDAMEDFDA UDI	Class I	Active
Comfort Grip™	DCG30SLIM	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S377	EUDAMEDFDA UDI	Class I	Active
Parkell®	DPL30	EUDAMEDFDA UDI	Class IIa	Active
GentleCLEAN™	DSG30GCW	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S373	EUDAMEDFDA UDI	Class I	Active
Hedgehog™	S501	EUDAMEDFDA UDI	Class I	Active
DryZ®	S186	EUDAMEDFDA UDI	Class I	Active
Mach-2	S433S	EUDAMEDFDA UDI	Class I	Active
Predicta™	S626	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S383	EUDAMEDFDA UDI	Class I	Active
GentleCLEAN™	DSG30GC	EUDAMEDFDA UDI	Class IIa	Active
Hedgehog™	S499	EUDAMEDFDA UDI	Class I	Active
Parkell®	S334	EUDAMEDFDA UDI	Class I	Active
PureClarity™	D719	EUDAMEDFDA UDI	Class I	Active
Parkell®	S390	EUDAMEDFDA UDI	Class I	Active
Blu-Mousse®	S436	EUDAMEDFDA UDI	Class I	Active
TurboSENSOR +™	D660	EUDAMEDFDA UDI	Class IIa	Active
Predicta™	S631	EUDAMEDFDA UDI	Class IIa	Active
TurboSENSOR +™	D722	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S292	EUDAMEDFDA UDI	Class I	Active
Parkell®	DSG30L	EUDAMEDFDA UDI	Class IIa	Active
Blu-Mousse®	S457S	EUDAMEDFDA UDI	Class I	Active
Cinch®	S456S	EUDAMEDFDA UDI	Class I	Active
Blu-Mousse®	S440S	EUDAMEDFDA UDI	Class I	Active
Parkell®	S343	EUDAMEDFDA UDI	Class I	Active
Parkell®	S621	EUDAMEDFDA UDI	Class I	Active
Parkell®	DPI30	EUDAMEDFDA UDI	Class IIa	Active
Parkell®	S328	EUDAMEDFDA UDI	Class I	Active
Parkell®	S379	EUDAMEDFDA UDI	Class I	Active
Parkell®	S472	EUDAMEDFDA UDI	Class I	Active

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