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Widex

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10985431Model RIC

by Widex A/S

Identity

Trade Name
HA MOMENT MRB0 330 MTQS EUDAMED
WIDEX FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-canal FDA UDI
Device Name
HA MOMENT MRB0 330 MTQS FDA UDI
Model / Reference
RIC EUDAMED
10985431 EUDAMED
MOMENT MRB0 330 FDA UDI
Description
HA MOMENT MRB0 330 MTQS FDA UDI

Identifiers

Catalog Number
10985431 FDA UDI
Primary DI / UDI-DI
05706069886184 EUDAMEDFDA UDI
Basic UDI-DI
5714880-WSA-65-15-5A EUDAMED
FDA Product Code
OSM FDA UDI
EMDN Code
Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
GMDN Term
Air-conduction hearing aid, receiver-in-canal FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Air-conduction hearing aid, receiver-in-canal

Widex by Widex A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, receiver-in-canal.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Widex A/S

Sources (2)

  • FDA UDI 67c8ca47-7f9c-4d76-9023-946fc3b062d5 35 fields · synced Jun 20, 2026
  • EUDAMED 531017fe-6341-4db8-af60-4a9c0a510c84 61 fields · synced Jun 20, 2026