← Back to catalogue

USB Jr Duet

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref M010300

by Intelligent Hearing Systems Corp.

Identity

Trade Name
USB Jr Duet EUDAMEDFDA UDI
Generic Name
Evoked-potential graphic recording system FDA UDI
Device Name
USB Jr Duet EUDAMED
Model / Reference
M010300 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00817020020075 EUDAMEDFDA UDI
Basic UDI-DI
08172002M010300EP EUDAMED
Direct Marketing DI
00817020020075 EUDAMED
510(k) Number
K023859 FDA UDI
K031051 FDA UDI
K070608 FDA UDI
K900096 FDA UDI
K964426 FDA UDI
FDA Product Code
GWJ FDA UDI
EWO FDA UDI
EMDN Code
Z12140301,Z12149001 EUDAMED
GMDN Term
Evoked-potential graphic recording system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.1900 FDA UDI
874.1050 FDA UDI
Market of Registration
Spain 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

USB Jr Duet by Intelligent Hearing Systems Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Intelligent Hearing Systems Corp.
EUDAMED SRN
US-MF-000011473
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (2)

  • EUDAMED 3e839d4a-d1b3-4430-8c8c-768b4945c185 61 fields · synced Jun 18, 2026
  • FDA UDI 32f8c92a-a2b7-40d2-ad74-dbf7d1a475c8 33 fields · synced May 30, 2026