Organization name

Starkey Laboratories Inc.

SRN

US-MF-000014382

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• MR UNSAFE

Primary placement in Germany; available across 32 countries total.

Trade name

Incognito GS 12 BTE 13 UP

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.

00840388212295

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.

0842318163400UP

Reference / catalog number

63433-F

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

—

Additional information URL

https://www.starkey.com/

Clinical sizes

No clinical sizes registered for this device.

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

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

• Y2145060101BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)

• Class IIa medical devices in EUDAMED

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