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Indirect Ophthalmoscope Monocular

FDA UDI

Class II (US FDA UDI)

by Heine Optotechnik GmbH & Co. KG

Identity

Trade Name
INDIRECT OPHTHALMOSCOPE MONOCULAR FDA UDI
Generic Name
Indirect monocular ophthalmoscope, electrically-powered FDA UDI
Model / Reference
3,5 V FDA UDI

Identifiers

Catalog Number
C-002.33.001 FDA UDI
Primary DI / UDI-DI
04053755120307 FDA UDI
FDA Product Code
HLI FDA UDI
GMDN Term
Indirect monocular ophthalmoscope, electrically-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1570 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indirect monocular ophthalmoscope, electrically-powered

Indirect Ophthalmoscope Monocular by Heine Optotechnik GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indirect monocular ophthalmoscope, electrically-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heine Optotechnik GmbH & Co. KG

Sources (1)

  • FDA UDI 8d3c54fa-4695-4df8-84e0-7375f0fe94ec 34 fields · synced May 29, 2026