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BBig B.V.

US

Last updated May 23, 2026

What BBig B.V. makes

BBig B.V. manufactures spectacle frames designed for corrective and fashion eyewear. The devices are intended for general use in optical prescriptions and include various styles and materials for different visual needs and preferences.

The company’s products are classified as Class I medical devices under US regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. BBig B.V. operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does BBig B.V. manufacture?

BBig B.V. specializes in spectacle frames, which are designed for both corrective and fashion eyewear. These devices are intended for general use in optical prescriptions and come in various styles and materials to cater to different visual needs and aesthetic preferences.

Where is BBig B.V. based, and how does that affect its regulatory standing?

BBig B.V. is based in the United States. Since its devices are regulated under US medical device laws, their classification and compliance requirements follow FDA guidelines. The company’s location ensures its products meet US-specific regulatory standards.

How are BBig B.V.’s devices classified under US regulations, and why?

BBig B.V.’s spectacle frames are classified as Class I medical devices under US regulations. This classification is typically assigned to low-risk devices where general controls are sufficient to ensure safety and effectiveness, such as spectacle frames, which pose minimal risk to users.

Are BBig B.V.’s devices listed in any regulatory registries, and if so, which ones?

Yes, BBig B.V.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for regulatory and market surveillance purposes.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
408104979

Catalogue (3664)

Page 67 of 74
DeviceModel / ReferenceRegistriesClassStatus
Bbig TR22836416
FDA UDI
Class IActive
Bbig TL42017127
FDA UDI
Class IActive
Bbig F8064413
FDA UDI
Class IActive
Bbig SPR177
FDA UDI
Class IActive
Bbig CR60347H01
FDA UDI
Class IActive
Bbig TR20736429
FDA UDI
Class IActive
Bbig F8014504
FDA UDI
Class IActive
Bbig F420437180
FDA UDI
Class IActive
Bbig M153699
FDA UDI
Class IActive
Bbig F21348371
FDA UDI
Class IActive
Bbig TR22740402
FDA UDI
Class IActive
Bbig F0014193
FDA UDI
Class IActive
Bbig F30154190
FDA UDI
Class IActive
Bbig TR20341345
FDA UDI
Class IActive
Bbig 21133410
FDA UDI
Class IActive
Bbig F03736238
FDA UDI
Class IActive
Bbig 20446402
FDA UDI
Class IActive
Bbig TL60345H03
FDA UDI
Class IActive
Bbig TL320248412
FDA UDI
Class IActive
Bbig F22740381
FDA UDI
Class IActive
Bbig TR20838356
FDA UDI
Class IActive
Bbig TL420181
FDA UDI
Class IActive
Bbig 60247H07
FDA UDI
Class IActive
Bbig F0154190
FDA UDI
Class IActive
Bbig TM166
FDA UDI
Class IActive
Bbig F420145155
FDA UDI
Class IActive
Bbig CL60345H03
FDA UDI
Class IActive
Bbig 0624796
FDA UDI
Class IActive
Bbig F22836386
FDA UDI
Class IActive
Bbig TL42033184
FDA UDI
Class IActive
Bbig F300544226
FDA UDI
Class IActive
Bbig 420847209
FDA UDI
Class IActive
Bbig 02337175
FDA UDI
Class IActive
Bbig TR8064413
FDA UDI
Class IActive
Bbig F21044371
FDA UDI
Class IActive
Bbig F22147404
FDA UDI
Class IActive
Bbig 01642101
FDA UDI
Class IActive
Bbig F03036225
FDA UDI
Class IActive
Bbig F21135370
FDA UDI
Class IActive
Bbig TR320248341
FDA UDI
Class IActive
Bbig F21133226
FDA UDI
Class IActive
Bbig TR22345406
FDA UDI
Class IActive
Bbig TR32026340
FDA UDI
Class IActive
Bbig TL21637425
FDA UDI
Class IActive
Bbig TL23346380
FDA UDI
Class IActive
Bbig TR20548349
FDA UDI
Class IActive
Bbig FM30153610
FDA UDI
Class IActive
Bbig TL4903474
FDA UDI
Class IActive
Bbig TR4206116
FDA UDI
Class IActive
Bbig TR60347H01
FDA UDI
Class IActive

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