Identity
- Trade Name
- Softec HD™ EUDAMEDSOFTEC HD FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- Softec HD EUDAMEDIOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) FDA UDI
- Model / Reference
- Softec HD™ EUDAMEDSOFTECHD+34.0 FDA UDI
- Description
- IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear) FDA UDI
Identifiers
- Catalog Number
- SOFTEC HD FDA UDI
- Primary DI / UDI-DI
- 00844369027731 EUDAMED00844369027649 EUDAMEDFDA UDI00844369027762 EUDAMED
- Basic UDI-DI
- B-00844369027731 EUDAMEDB-00844369027649 EUDAMEDB-00844369027762 EUDAMED
- PMA Number
- P090022 FDA UDI
- FDA Product Code
- HQL FDA UDI
- EMDN Code
- P030102090202 IOLs, APHAKIC, MONOFOCAL, 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
- Germany 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 HD™ 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-00844369027731 | 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 fe1fb4bf-e8bc-47bc-8a8f-aa6f3a3eb0c7 61 fields · synced Jul 29, 2026
- EUDAMED e97f4a4c-2d77-4199-9c12-88bbdc46c2a0 61 fields · synced May 18, 2026
- EUDAMED 3edd149e-5597-44ae-b605-50512fe59568 61 fields · synced May 19, 2026
- FDA UDI 360dcc3a-ed91-43ae-ba5f-e29253d3f34b 38 fields · synced May 30, 2026