Identity
- Trade Name
- SBL-2™ EUDAMED
- Device Name
- SBL-2 EUDAMED
- Model / Reference
- SBL-2™ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844369012508 EUDAMED00844369011891 EUDAMED00844369011914 EUDAMED00844369012522 EUDAMED00844369011624 EUDAMED00844369012690 EUDAMED00844369012782 EUDAMED00844369012614 EUDAMED00844369011709 EUDAMED00844369011631 EUDAMED00844369011884 EUDAMED00844369012652 EUDAMED00844369011945 EUDAMED00844369011716 EUDAMED00844369011792 EUDAMED00844369012584 EUDAMED00844369012768 EUDAMED00844369012744 EUDAMED00844369012751 EUDAMED00844369012577 EUDAMED00844369011723 EUDAMED00844369011617 EUDAMED00844369011976 EUDAMED00844369012515 EUDAMED00844369012621 EUDAMED00844369011761 EUDAMED00844369011846 EUDAMED00844369011686 EUDAMED00844369012539 EUDAMED00844369011648 EUDAMED00844369012485 EUDAMED00844369011853 EUDAMED00844369011785 EUDAMED00844369011921 EUDAMED00844369011983 EUDAMED00844369011969 EUDAMED00844369011822 EUDAMED00844369012706 EUDAMED
- Basic UDI-DI
- B-00844369012508 EUDAMEDB-00844369011891 EUDAMEDB-00844369011914 EUDAMEDB-00844369012522 EUDAMEDB-00844369011624 EUDAMEDB-00844369012690 EUDAMEDB-00844369012782 EUDAMEDB-00844369012614 EUDAMEDB-00844369011709 EUDAMEDB-00844369011631 EUDAMEDB-00844369011884 EUDAMEDB-00844369012652 EUDAMEDB-00844369011945 EUDAMEDB-00844369011716 EUDAMEDB-00844369011792 EUDAMEDB-00844369012584 EUDAMEDB-00844369012768 EUDAMEDB-00844369012744 EUDAMEDB-00844369012751 EUDAMEDB-00844369012577 EUDAMEDB-00844369011723 EUDAMEDB-00844369011617 EUDAMEDB-00844369011976 EUDAMEDB-00844369012515 EUDAMEDB-00844369012621 EUDAMEDB-00844369011761 EUDAMEDB-00844369011846 EUDAMEDB-00844369011686 EUDAMEDB-00844369012539 EUDAMEDB-00844369011648 EUDAMEDB-00844369012485 EUDAMEDB-00844369011853 EUDAMEDB-00844369011785 EUDAMEDB-00844369011921 EUDAMEDB-00844369011983 EUDAMEDB-00844369011969 EUDAMEDB-00844369011822 EUDAMEDB-00844369012706 EUDAMED
- EMDN Code
- P030102100202 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Sbl-2™ by Lenstec Barbados Inc — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00844369012508 | Class IIb | Active |
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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 (38)
- EUDAMED 92ea2b25-3aea-4159-8034-df48372dd3bf 61 fields · synced Sep 18, 2026
- EUDAMED 10ca1baa-9d2b-48e7-9374-b3f1262e24d0 61 fields · synced May 11, 2026
- EUDAMED 159a992e-209e-412a-a43e-e0a7a75e0f18 61 fields · synced May 11, 2026
- EUDAMED 16b27414-4f66-486d-901d-b4ebf5cdc5e7 61 fields · synced May 11, 2026
- EUDAMED d4d11cb5-dabf-4f5e-bb9d-b2de68582c3a 61 fields · synced May 16, 2026
- EUDAMED 0e1f1157-cd3e-4c7b-bf8e-d17677cd9de8 61 fields · synced May 16, 2026
- EUDAMED e8b62209-d715-4e8d-bc9d-a059189210d7 61 fields · synced May 16, 2026
- EUDAMED 3559aa85-e755-4b17-8bb7-76876e5c7fa6 61 fields · synced May 16, 2026
- EUDAMED b4c03867-0366-4c26-ba68-71e58cf7308e 61 fields · synced May 16, 2026
- EUDAMED 56f45d06-230a-4553-a940-456f74e75a1a 61 fields · synced May 16, 2026
- EUDAMED f80412da-53a6-495d-aedd-14b12e45f046 61 fields · synced May 17, 2026
- EUDAMED 2f951fc9-af29-4b7c-86cc-111d7f358421 61 fields · synced May 17, 2026
- EUDAMED 617c9cbf-c577-4fb6-b9ec-e16a20e29ad4 61 fields · synced May 17, 2026
- EUDAMED c9e71d4d-7ab7-4f3f-9790-6f5f6ffb9451 61 fields · synced May 17, 2026
- EUDAMED d83916d8-5b73-4cee-a588-5122ff1972e6 61 fields · synced May 17, 2026
- EUDAMED 3220c26a-8fab-4597-a267-5e0b18cd5287 61 fields · synced May 17, 2026
- EUDAMED f8c02861-8e03-4938-b101-37669c6293f8 61 fields · synced May 17, 2026
- EUDAMED e0397b37-9b92-43b9-ac9f-cdc0a4eed12a 61 fields · synced May 17, 2026
- EUDAMED 50aa43be-df3a-49c1-8d1d-710037b7f35d 61 fields · synced May 17, 2026
- EUDAMED 624de4f3-ae03-4261-a5b5-72802a1c1721 61 fields · synced May 17, 2026
- EUDAMED 80c96d1e-aa9a-44ab-a7ac-5f15b683470a 61 fields · synced May 18, 2026
- EUDAMED a05cad4d-f48b-4524-bea4-33d2e02c6bfe 61 fields · synced May 18, 2026
- EUDAMED 9983ce68-0fe7-4bac-a04e-cde49b0fc83e 61 fields · synced May 19, 2026
- EUDAMED 911e07da-1531-45db-8541-5229a9874634 61 fields · synced May 19, 2026
- EUDAMED c1a8beba-bba1-498f-b894-469ad10879c8 61 fields · synced May 19, 2026
- EUDAMED 006634ae-3e11-4eec-b178-fae0ba429407 61 fields · synced May 19, 2026
- EUDAMED 50a447c0-76a7-4297-8a38-a6bcbd9d6de9 61 fields · synced May 19, 2026
- EUDAMED c82aa7b4-faa3-45ea-a494-9b8315966527 61 fields · synced May 19, 2026
- EUDAMED 3c3e8db0-a271-41be-9ff7-ca0534869c33 61 fields · synced May 19, 2026
- EUDAMED 80b0b7f2-ee07-46c8-8bd4-783c1797ce48 61 fields · synced May 19, 2026
- EUDAMED c1a05e10-752f-4006-96ad-e31b8ac6f83d 61 fields · synced May 19, 2026
- EUDAMED 21600670-7510-4dbc-ad01-f40262405407 61 fields · synced May 19, 2026
- EUDAMED 45b946df-9250-4997-8a63-4db7797f7635 61 fields · synced May 19, 2026
- EUDAMED 2fe62a6f-950c-4204-9e25-8d921c9f5239 61 fields · synced May 19, 2026
- EUDAMED 72d51071-4136-43af-9b94-faf5da7ca5a0 61 fields · synced May 19, 2026
- EUDAMED 123654a6-dd63-431e-ab38-1881c9301fba 61 fields · synced May 19, 2026
- EUDAMED fd22e8fd-b8af-4c03-87b9-ad63a0e5ac5f 61 fields · synced May 19, 2026
- EUDAMED a0d009a9-78dc-4f0b-a48e-e99443e99bf7 61 fields · synced May 19, 2026