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 2.7 x 34 mm, 0° FDA UDI
Model / Reference: 02-4305 FDA UDI
Description: Otoscope 2.7 x 34 mm, 0° FDA UDI

Identifiers

Primary DI / UDI-DI: 04250480107331 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

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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COMBILIGHT F.O.30 otoscope with charg. plug 240 V + accu 3.5 V — Kirchner & Wilhelm GmbH + Co KG · Class I
Otoscope — Ecleris · Class I
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
Ear funnel, Ø 4.5 mm PU = 3 pcs. — Kirchner & Wilhelm GmbH + Co KG · Class I
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 252b6793-62a9-4a70-93b1-88a4bc4778d0 36 fields · synced Jun 8, 2026