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Starkey

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 63283-1Model Receiver-In-Canal (RIC)

by Starkey Laboratories Inc.

Identity

Trade Name
STARKEY EVOLV AI 2400 MRIC 312 EUDAMED
STARKEY FDA UDI
Generic Name
Tinnitus masking application software FDA UDI
Device Name
Evolv AI EUDAMED
Model / Reference
Receiver-In-Canal (RIC) EUDAMED
63283-1 EUDAMED
STARKEY EVOLV AI 2400 MRIC 312 FDA UDI

Identifiers

Primary DI / UDI-DI
00842318184658 EUDAMEDFDA UDI
Basic UDI-DI
0842318163276VE EUDAMED
FDA Product Code
KLW FDA UDI
OSM FDA UDI
EMDN Code
Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
GMDN Term
Tinnitus masking application software FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
874.3400 FDA UDI
874.3305 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-canalTinnitus masking application software

Starkey by Starkey Laboratories Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Tinnitus masking application software.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Starkey Laboratories Inc.

Sources (2)

  • FDA UDI 5574253f-e689-4a3c-93cd-6ee2d4fd9895 33 fields · synced Jun 18, 2026
  • EUDAMED 0172b2fc-87af-449a-a118-7db9b66f98ba 61 fields · synced Jun 18, 2026