Reia

FDA UDI

Class I (US FDA UDI)

by Reia, LLC

Identity

Trade Name: Reia FDA UDI
Generic Name: Vaginal applicator, reusable FDA UDI
Device Name: Size 3 Applicator FDA UDI
Model / Reference: AA01-3 FDA UDI
Description: Size 3 Applicator FDA UDI

Identifiers

Primary DI / UDI-DI: 00860012119387 FDA UDI
FDA Product Code: HGD FDA UDI
GMDN Term: Vaginal applicator, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Vaginal applicator, reusable

Reia by Reia, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal applicator, reusable.

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Ring applicator — SOPRO-COMEG GmbH · Class II
Pixie Cup — Pixie Cup, LLC · Class I
Premarin (conjugated estrogens) vaginal cream — Wyeth Pharmaceuticals LLC · Class I
Ring applicator — SOPRO-COMEG GmbH · Class II
Applicator — SOPRO-COMEG GmbH · Class II
CLEOCIN® (clindamycin phosphate vaginal suppositories) Vaginal Ovules — Pharmacia & Upjohn Co. · Class I
Vaginal Applicator — MAI/GENESIS · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Reia, LLC

Sources (1)

FDA UDI 9ddf32d3-2b6f-4149-832d-558ad6fc48c1 33 fields · synced Jun 8, 2026