Identity
- Trade Name
- Softec I™ EUDAMEDSOFTEC I FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- Softec I EUDAMEDIOL - HEMA - 1pc 5.75/12.0mm FDA UDI
- Model / Reference
- Softec I™ EUDAMEDSOFTECI+29.0 FDA UDI
- Description
- IOL - HEMA - 1pc 5.75/12.0mm FDA UDI
Identifiers
- Catalog Number
- SOFTEC I FDA UDI
- Primary DI / UDI-DI
- 00844369015493 EUDAMED00844369029742 EUDAMEDFDA UDI00844369015486 EUDAMED
- Basic UDI-DI
- B-00844369015493 EUDAMEDB-00844369029742 EUDAMEDB-00844369015486 EUDAMED
- PMA Number
- P090022 FDA UDI
- FDA Product Code
- HQL FDA UDI
- EMDN Code
- P030102090102 IOLs, APHAKIC, MONOFOCAL, SPHERICAL, 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
- Germany EUDAMEDHungary 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
Softec I™ 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-00844369015493 | 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 (4)
- EUDAMED eb38103f-a5f8-42b2-83d0-ff4673b49d75 61 fields · synced Aug 4, 2026
- EUDAMED e1ef7744-48c0-4617-896d-dd63868d46d3 61 fields · synced May 18, 2026
- EUDAMED 52a8e8eb-5112-469b-8448-97eaad97e1d3 61 fields · synced May 18, 2026
- FDA UDI b330764a-4aba-4c7e-972b-918ee325edec 38 fields · synced May 30, 2026