Organization name

Applied Medical Technology, Inc.

SRN

US-MF-000041414

Manufacturer status

Active

5 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW026

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Ireland; available across 21 countries total.

Trade name

MiniONE® Balloon Button - Low Profile Gastrostomy Feeding Tube

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00842071141394

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

08420711BALLOONBUTTON7U

Reference / catalog number

M1-5-1650-I

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

ENFit®

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 16 MU170
• 5 MU10

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• G02020201GASTROSTOMY, TUBES AND SETS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.