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Aquarius Stoma Measuring Device

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K152246Ref 102148101280AQ

by Degania Silicone Ltd

Identity

Trade Name
Aquarius FDA UDI
Generic Name
Gastrostomy depth sizer FDA UDI
Device Name
Stoma measuring EUDAMED
STOMA MEASURING DEVICE 12FR FDA UDI
Model / Reference
102148101280AQ EUDAMEDFDA UDI
Description
STOMA MEASURING DEVICE 12FR FDA UDI

Identifiers

Primary DI / UDI-DI
07290001603994 EUDAMEDFDA UDI
Basic UDI-DI
7290001603V300SMDR3 EUDAMED
510(k) Number
K152246 FDA 510(k)
FDA Product Code
KNT FDA 510(k)FDA UDI
EMDN Code
V0399 MEASUREMENT DEVICES - OTHER EUDAMED
GMDN Term
Gastrostomy depth sizer FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.5980 FDA 510(k)
Regulation Number
876.5980 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Aquarius Stoma Measuring Device is a Stoma Measuring Device (UDI Classification: KNT), designed to accurately measure the diameter and depth of stoma openings in patients with ostomies. It provides precise sizing to ensure proper fitment of ostomy appliances, reducing the risk of leakage or skin irritation. Constructed from medical-grade silicone, the device is engineered for clinical use in gastroenterology and urology settings.

This device is supplied as a single-use, non-sterile instrument intended for use in outpatient clinics, hospitals, or home healthcare environments. It is available in a range of sizes to accommodate varying stoma diameters, and storage instructions specify protection from direct sunlight and extreme temperatures. Authorised under FDA 510K clearance and MDR compliance, the Aquarius Stoma Measuring Device adheres to regulatory standards for medical devices in stoma care.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Degania Silicone Ltd
FDA Applicant
Degania Silicone , Ltd.

Sources (3)

  • FDA 510(k) K152246 24 fields · synced Sep 18, 2026
  • FDA UDI 070c508c-688e-42a5-9fce-6ba5be3a081f 33 fields · synced May 30, 2026
  • EUDAMED e0a3568b-2d5a-495b-8c26-3ee87d0dfede 61 fields · synced Jul 22, 2026