Hr

FDA UDI

Class I (US FDA UDI)

by Heine Optotechnik GmbH & Co. KG

Identity

Trade Name: HR FDA UDI
Generic Name: Surgical binoculars, reusable FDA UDI
Model / Reference: 2.5 x 340 mm FDA UDI

Identifiers

Catalog Number: C-000.32.355 FDA UDI
Primary DI / UDI-DI: 04053755118045 FDA UDI
FDA Product Code: HJH FDA UDI
GMDN Term: Surgical binoculars, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.5120 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

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

Category: Surgical binoculars, reusable

Hr by Heine Optotechnik GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical binoculars, reusable.

Brilliance — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class I
Enova Illumination — ENOVA ILLUMINATION, INC · Class I
SurgiTel — Surgitel · Class I
Surgical Telescope — Xenosys Co., Ltd. · Class I
Brasseler USA — Peter Brasseler Holdings, LLC · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SuperVu XL Advantage 3.5x, at 34cm working distanc — Rudolf Riester GmbH & Co. KG · Class I
Surgical Telescope — Xenosys Co., 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

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

Manufacturer

Manufacturer: Heine Optotechnik GmbH & Co. KG

Sources (1)

FDA UDI c178c52a-28b5-4ad9-b8ee-92c0be525c64 34 fields · synced Jun 1, 2026