Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBBig 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
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 408104979
Catalogue (3664)
Page 19 of 74| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bbig | TR20548347 | FDA UDI | Class I | Active |
| Bbig | TM393 | FDA UDI | Class I | Active |
| Bbig | TL320246380 | FDA UDI | Class I | Active |
| Bbig | TL22045390 | FDA UDI | Class I | Active |
| Bbig | F320246371 | FDA UDI | Class I | Active |
| Bbig | TR4208202 | FDA UDI | Class I | Active |
| Bbig | TM3101 | FDA UDI | Class I | Active |
| Bbig | 60738H01 | FDA UDI | Class I | Active |
| Bbig | 02638211 | FDA UDI | Class I | Active |
| Bbig | 8014704 | FDA UDI | Class I | Active |
| Bbig | TL8004105 | FDA UDI | Class I | Active |
| Bbig | TL20836356 | FDA UDI | Class I | Active |
| Bbig | TR420103 | FDA UDI | Class I | Active |
| Bbig | TR06145206 | FDA UDI | Class I | Active |
| Bbig | F20444354 | FDA UDI | Class I | Active |
| Bbig | TL42024148 | FDA UDI | Class I | Active |
| Bbig | 02243161 | FDA UDI | Class I | Active |
| Bbig | 02442177 | FDA UDI | Class I | Active |
| Bbig | 0194190 | FDA UDI | Class I | Active |
| Bbig | TR20741350 | FDA UDI | Class I | Active |
| Bbig | TL23441440 | FDA UDI | Class I | Active |
| Bbig | TR20938384 | FDA UDI | Class I | Active |
| Bbig | TL22640405 | FDA UDI | Class I | Active |
| Bbig | TR40017155 | FDA UDI | Class I | Active |
| Bbig | F00444101 | FDA UDI | Class I | Active |
| Bbig | TR42017127 | FDA UDI | Class I | Active |
| Bbig | SP14451 | FDA UDI | Class I | Active |
| Bbig | 02139160 | FDA UDI | Class I | Active |
| Bbig | 21548366 | FDA UDI | Class I | Active |
| Bbig | F400145140 | FDA UDI | Class I | Active |
| Bbig | F03240231 | FDA UDI | Class I | Active |
| Bbig | 20147337 | FDA UDI | Class I | Active |
| Bbig | 4903455 | FDA UDI | Class I | Active |
| Bbig | 20548349 | FDA UDI | Class I | Active |
| Bbig | 03441239 | FDA UDI | Class I | Active |
| Bbig | 02442175 | FDA UDI | Class I | Active |
| Bbig | F301642100 | FDA UDI | Class I | Active |
| Bbig | 420244149 | FDA UDI | Class I | Active |
| Bbig | F301539225 | FDA UDI | Class I | Active |
| Bbig | TL22638413 | FDA UDI | Class I | Active |
| Bbig | TR4903453 | FDA UDI | Class I | Active |
| Bbig | TR4208204 | FDA UDI | Class I | Active |
| Bbig | TL22445388 | FDA UDI | Class I | Active |
| Bbig | TL20838226 | FDA UDI | Class I | Active |
| Bbig | 03441233 | FDA UDI | Class I | Active |
| Bbig | F21044363 | FDA UDI | Class I | Active |
| Bbig | 02243164 | FDA UDI | Class I | Active |
| Bbig | TR60043H03 | FDA UDI | Class I | Active |
| Bbig | F21639384 | FDA UDI | Class I | Active |
| Bbig | TR21449378 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.