Identity
- Trade Name
- SBL-3™ EUDAMEDClearView 3 FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- SBL-3 EUDAMEDMultifocal IOL modified plate, HEMA FDA UDI
- Model / Reference
- SBL-3™ EUDAMEDSBL-3+24.5 FDA UDI
- Description
- Multifocal IOL modified plate, HEMA FDA UDI
Identifiers
- Catalog Number
- SBL-3 FDA UDI
- Primary DI / UDI-DI
- 00844369038485 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00844369038485 EUDAMED
- PMA Number
- P200020 FDA UDI
- FDA Product Code
- MFK FDA UDI
- EMDN Code
- P030102100202 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC EUDAMED
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sbl-3™ by Lenstec Barbados Inc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00844369038485 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Lenstec (Barbados) Inc.
- EUDAMED SRN
- BB-MF-000019262
- Authorised Representative
- CMI spol. s r.o. SK-AR-000007425
Sources (2)
- EUDAMED 6c6881ef-bb41-4338-a0ee-c894cda5a5af 61 fields · synced Jul 19, 2026
- FDA UDI fe74a1b6-6dae-4413-92a7-d808d64cf4ea 38 fields · synced May 30, 2026