pma Primary ID: P000006

ALPHA I INFLATABLE PENILE PROSTHESIS (UDI P000006)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The ALPHA I INFLATABLE PENILE PROSTHESIS (Model/Catalog Number: Unspecified) is a medical device manufactured by Coloplast Corp.. This product is indexed under FDA Product Code / Category Classification FHW within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: N/A
Product Code / EMDN: FHW
Device Name: Device, impotence, mechanical/hydraulic
Database Sync Date: 2026-08-09 10:06:13

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of ALPHA I INFLATABLE PENILE PROSTHESIS?

The registered manufacturer of record for ALPHA I INFLATABLE PENILE PROSTHESIS is Coloplast Corp..

What is the Primary UDI-DI identifier for ALPHA I INFLATABLE PENILE PROSTHESIS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P000006.

What classification code is assigned to this device?

This device is registered under product classification code FHW.

Similar Classification Devices (FHW)

Other Devices by Coloplast Corp.

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