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GN Otometrics A/S

FDA UDI

Class I (US FDA UDI)

by Natus Medical Denmark ApS

Identity

Trade Name
GN Otometrics A/S FDA UDI
Generic Name
Diagnostic caloric vestibular stimulation system FDA UDI
Model / Reference
Specula, disposable FDA UDI

Identifiers

Primary DI / UDI-DI
05713315002533 FDA UDI
FDA Product Code
KHH FDA UDI
GMDN Term
Diagnostic caloric vestibular stimulation system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.1800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic caloric vestibular stimulation system

GN Otometrics A/S by Natus Medical Denmark ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic caloric vestibular stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Denmark ApS

Sources (1)

  • FDA UDI 974e58ca-99af-4b40-a1de-8746f64f6016 32 fields · synced Jun 6, 2026