BETA X Otoscope

FDA UDI

Class I (US FDA UDI)

by Heine Optotechnik GmbH & Co. KG

Identity

Trade Name: BETA X Otoscope FDA UDI
Generic Name: Otoscope, direct FDA UDI
Device Name: Set containing X CHANGE System 4.2 x Magnifier, 10 x AllSpec 4 mm disposable tips FDA UDI
Model / Reference: 4.2 x FDA UDI
Description: Set containing X CHANGE System 4.2 x Magnifier, 10 x AllSpec 4 mm disposable tips FDA UDI

Identifiers

Catalog Number: B-131.28.330 FDA UDI
Primary DI / UDI-DI: 04053755202911 FDA UDI
FDA Product Code: ERA FDA UDI
GMDN Term: Otoscope, direct 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

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: Otoscope, direct

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

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Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
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BV Medical — Medical, Inc. · 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: Heine Optotechnik GmbH & Co. KG

Sources (1)

FDA UDI ff500b31-b00e-4d51-a0a2-6b40767ed24a 35 fields · synced Jun 8, 2026