PrimeSight

FDA UDI

Class I (US FDA UDI)

by SCHÖLLY FIBEROPTIC GmbH

Identity

Trade Name: PrimeSight FDA UDI
Generic Name: Otoscope, endoscopic FDA UDI
Device Name: Otoscope 4 x 50 mm, 30° FDA UDI
Model / Reference: 02-4303 FDA UDI
Description: Otoscope 4 x 50 mm, 30° FDA UDI

Identifiers

Primary DI / UDI-DI: 04250480107300 FDA UDI
FDA Product Code: ERA FDA UDI
GMDN Term: Otoscope, endoscopic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Otoscope, endoscopic

PrimeSight by SCHÖLLY FIBEROPTIC GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Otoscope Set, VISIO 5, Classic F.O., 2.5V XENON — Medical Devices (Pvt) Ltd · Class I
Otoscopes — Hangzhou Hawk Optical Electronic Instruments Co.,Ltd. · Class I
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Otoscope Set, OMNI 3000, Deluxe, Xenon, Blue — Medical Devices (Pvt) Ltd · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: SCHÖLLY FIBEROPTIC GmbH

Sources (1)

FDA UDI 829edba6-ffaa-4644-86d2-4b8a73245cd1 36 fields · synced May 30, 2026