medicalprint shell beige 2.0 1000g

GUDID EDET030161

DETAX GmbH

Earmould, custom-made

• Primary Device ID: EDET030161
• NIH Device Record Key: 372b4c38-e795-4c2a-9210-9484e923854b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: medicalprint shell beige 2.0 1000g
• Version Model Number: 03016
• Company DUNS: 343947949
• Company Name: DETAX GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDET030161 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air-Conduction, Prescription

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: 2026-03-05
• Device Publish Date: 2026-02-25

Devices Manufactured by DETAX GmbH

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• EDET045581 - medicalprint nobreak blue-transparent 1000g: 2025-12-30