Béa Fertility

GUDID 05065015660002

Béa Applicator

STEPONE FERTILITY LTD

Conceptive cervical cap, single-use

• Primary Device ID: 05065015660002
• NIH Device Record Key: 2a6decdc-42f8-42e3-a3e9-8315b14c8b11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Béa Fertility
• Version Model Number: BAP-GB-01
• Company DUNS: 225808762
• Company Name: STEPONE FERTILITY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05065015660002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242031

FDA Product Code

• HDR: Cap, Cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-01
• Device Publish Date: 2025-07-24

On-Brand Devices [Béa Fertility]

• 05065015660064: Béa Treatment Kit
• 05065015660002: Béa Applicator