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First Quality Hygienic, Inc.

Last updated May 25, 2026

Information

Country: US
Address: —
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 806731840

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
Femtex	FT11804UA/FT11812UO	FDA UDI	Class II	Active
Femtex	FT22004F	FDA UDI	Class II	Active
Femtex	FT11812SO	FDA UDI	Class II	Active
Femtex	FT64003FN	FDA UDI	Class II	Active
Family Wellness Tampons	10001202	FDA UDI	Class II	Active
Femtex	FT10824F/1	FDA UDI	Class II	Active
Family Wellness Tampons	10001201	FDA UDI	Class II	Active
Femtex	FT13606UO	FDA UDI	Class II	Active
Family Wellness Tampons	100002510	FDA UDI	Class II	Active
Femtex	FT30824F/1	FDA UDI	Class II	Active
Femtex	FT24012FN/1	FDA UDI	Class II	Active
Femtex	FT34012FN/1	FDA UDI	Class II	Active
Femtex	FT21812UO/2	FDA UDI	Class II	Active
Femtex	FT14012FN/1	FDA UDI	Class II	Active
Family Wellness Tampons	10001688	FDA UDI	Class II	Active
Femtex	FT31804UA	FDA UDI	Class II	Active
Family Wellness Tampons	100002843	FDA UDI	Class II	Active
Family Wellness Tampons	10001203	FDA UDI	Class II	Active
Femtex	FT21804SA	FDA UDI	Class II	Active
Family Wellness Tampons	100002844	FDA UDI	Class II	Active
Femtex	FT12004F	FDA UDI	Class II	Active
Femtex	FT32004F	FDA UDI	Class II	Active
Femtex	FT62603UA	FDA UDI	Class II	Active
Femtex	FT20624UA	FDA UDI	Class II	Active
Femtex	FT10624UA	FDA UDI	Class II	Active
Family Wellness Tampons	100003075	FDA UDI	Class II	Active
Femtex	FT20824F/1	FDA UDI	Class II	Active
Private Labels And Femtex	K920238	FDA 510(k)	Class II	Active
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl	K161877	FDA 510(k)	Class II	Active
Femtex And Private Label Plastic Applicator Tampons	K050660	FDA 510(k)	Class II	Active
Femtex Junior/Slender Regular Open-End Tampons	K031067	FDA 510(k)	Class II	Active
Free Choice	K963032	FDA 510(k)	Class II	Active
Femtex Tampons And Other Private Label Plastic Applicator Tampons; Consumer Packages And Bulk Packages	K023479	FDA 510(k)	Class II	Active
Femtex And Private Label Scented Plastic Applicator Tampons	K032173	FDA 510(k)	Class II	Active
Femtex And Private Label Opal Fresh Scented Plastic Applicator Tampons	K051446	FDA 510(k)	Class II	Active
Femtex And Private Label Scented Plastic Applicator Tampons	K050067	FDA 510(k)	Class II	Active
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency	K151470	FDA 510(k)	Class II	Active
Femtex Gentle Touch Tampons	K963034	FDA 510(k)	Class II	Active

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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
Mar 25, 2010	Z-2466-2010	—	terminated	Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons.