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FDA 510(k)

Unscented menstrual three-piece applicator tampon

K-Number: K252613 · 2025-09-19

ApplicantUnibeauty (Hubei) Technology Co., Ltd.
Decision Date2025-09-19
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Unscented menstrual three-piece applicator tampon is the device name listed in this FDA 510(k) record. The listed applicant is Unibeauty (Hubei) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K252613. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unscented menstrual three-piece applicator tampon?

Unscented menstrual three-piece applicator tampon is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Unibeauty (Hubei) Technology Co., Ltd.. The 510(k) number is K252613.

When did Unscented menstrual three-piece applicator tampon receive FDA 510(k) clearance?

Unscented menstrual three-piece applicator tampon received FDA 510(k) clearance on 2025-09-19, under 510(k) number K252613.

Who is the listed applicant for Unscented menstrual three-piece applicator tampon?

The FDA 510(k) record lists Unibeauty (Hubei) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unscented menstrual three-piece applicator tampon?

The FDA product code for Unscented menstrual three-piece applicator tampon is HEB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07561905Tampon Safety-in-Use StudyRECRUITING

Other records listing Unibeauty (Hubei) Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsK251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsK232598Unscented Menstrual Tampon

Related Devices (Code: HEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252005Livi DeviceLiviwell, Inc.K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V.K241064Unscented TamponShandong Intco Hygiene Products Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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