Bbig

FDA UDI

Class I (US FDA UDI)

by BBig B.V.

Identity

Trade Name: BBIG FDA UDI
Generic Name: Spectacle frame FDA UDI
Device Name: TR8003905 FDA UDI
Model / Reference: TR8003905 FDA UDI
Description: TR8003905 FDA UDI

Identifiers

Primary DI / UDI-DI: 08719616039428 FDA UDI
FDA Product Code: HQZ FDA UDI
GMDN Term: Spectacle frame FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.5842 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

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Expiration Date

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Manufacturing Date

FDA UDI

Category: Spectacle frame

A comprehensive medical device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It is typically made of plastic or metallic frame, supported by the nose and ears, and may have a protective function.

Similar devices

Also classified as Spectacle frame.

Fielmann — Fielmann Group AG · Class I
Fysh — WestGroupe Optical Inc · Class I
Kliik:denmark Eyewear — WestGroupe Optical Inc · Class I
Fielmann — Fielmann Group AG · Class I
EYEWEAR BY ROI WOODBURY BROWN — Eyewear By Roi, Limited · Class I
Daniel Hechter — MPG GmbH · Class I
Kazuo Kawasaki — MASUNAGA OPTICAL MFG.CO., LTD. · Class I
Superflex Kids Collection — WestGroupe Optical 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: BBig B.V.

Sources (1)

FDA UDI 95af9ccc-e1bc-4374-929b-7d797198da19 33 fields · synced Jul 24, 2026