Aqua Liner XL

FDA UDI

Class I (US FDA UDI)

by Romedis GmbH

Identity

Trade Name: Aqua Liner XL FDA UDI
Generic Name: External limb prosthesis socket liner FDA UDI
Device Name: Liner to be used over residual limb FDA UDI
Model / Reference: SA701.5XL FDA UDI
Description: Liner to be used over residual limb FDA UDI

Identifiers

Catalog Number: SA701.5XL FDA UDI
Primary DI / UDI-DI: 04260652350052 FDA UDI
FDA Product Code: ISS FDA UDI
GMDN Term: External limb prosthesis socket liner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3420 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

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

Yes

FDA UDI

Category: External limb prosthesis socket liner

Aqua Liner XL by Romedis GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Romedis GmbH

Sources (1)

FDA UDI 5bc92311-4a52-4298-9396-fee1e43ca64c 34 fields · synced May 30, 2026