77733399

GUDID 09120041050572

extension tip; AN-Evo1; contact star evo1

BHM-Tech Produktionsgesellschaft m.b.H.

Head-worn bone-conduction hearing aid

• Primary Device ID: 09120041050572
• NIH Device Record Key: fee98d18-1298-4825-9c06-64d3e3da9ff6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EXTENSION-TIP/7/GO
• Catalog Number: 77733399
• Company DUNS: 300632705
• Company Name: BHM-Tech Produktionsgesellschaft m.b.H.
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +43335920078
• Email: nice_2_hear_u@bhm-tech.at

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120041050572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121793

FDA Product Code

• LXB: Hearing Aid, Bone Conduction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-21

Devices Manufactured by BHM-Tech Produktionsgesellschaft m.b.H.

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• 09120041052156 - contact: 2026-02-25 bone conduction hearing aid, RT/red