Identity
- Trade Name
- Boston EO EUDAMEDFDA UDI
- Generic Name
- Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
- Device Name
- Boston EO (enflufocon B) Rigid Gas Permeable Contact Lenses EUDAMEDRigid Gas Permeable Contact Lens FDA UDI
- Model / Reference
- Spec0301 EUDAMEDenflufocon B FDA UDI
- Description
- Rigid Gas Permeable Contact Lens FDA UDI
Identifiers
- Catalog Number
- Boston EO FDA UDI
- Primary DI / UDI-DI
- 0196527M0066H8 EUDAMED0196527M0065H6 EUDAMED00785811435691 FDA UDI
- Basic UDI-DI
- 0310119B0033Z6 EUDAMED
- FDA Product Code
- HQD FDA UDI
- EMDN Code
- Q02100402 CONTACT LENSES - NON HYDROGEL EUDAMED
- GMDN Term
- Rigid-gas-permeable corrective contact lens, daily-wear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.5916 FDA UDI
- Special Device Type
- Standard Rigid Gas Permeable (RGP) Contact Lenses EUDAMED
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Rigid-gas-permeable corrective contact lens, daily-wear
Boston EO by Bausch & Lomb Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
Sources (3)
- FDA UDI fa7b66c8-b1f3-4a9a-a95e-c5d9024121d9 34 fields · synced Oct 6, 2026
- EUDAMED f1d22888-d737-42ff-a421-bb5cf5d89d14 61 fields · synced Jul 12, 2026
- EUDAMED ce43c629-6c61-495f-acde-dc5a6bb2226f 61 fields · synced Jul 23, 2026