Identity
- Trade Name
- Softec HDY™ EUDAMED
- Device Name
- Softec HDY™ EUDAMEDSoftec HDY EUDAMED
- Model / Reference
- Softec HDY™ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844369026246 EUDAMED00844369026017 EUDAMED00844369026024 EUDAMED00844369026475 EUDAMED00844369026284 EUDAMED00844369026666 EUDAMED00844369026307 EUDAMED00844369026161 EUDAMED00844369026659 EUDAMED00844369026710 EUDAMED00844369026376 EUDAMED00844369026444 EUDAMED00844369026611 EUDAMED00844369026185 EUDAMED00844369026178 EUDAMED00844369026369 EUDAMED00844369026574 EUDAMED00844369026628 EUDAMED00844369026222 EUDAMED00844369026000 EUDAMED00844369026352 EUDAMED00844369026482 EUDAMED00844369026499 EUDAMED00844369026253 EUDAMED00844369026536 EUDAMED00844369026154 EUDAMED00844369026703 EUDAMED00844369026314 EUDAMED00844369026680 EUDAMED00844369026413 EUDAMED00844369026208 EUDAMED00844369026734 EUDAMED00844369026635 EUDAMED00844369026567 EUDAMED00844369026543 EUDAMED00844369026277 EUDAMED00844369026338 EUDAMED00844369026116 EUDAMED00844369026093 EUDAMED00844369026505 EUDAMED00844369026086 EUDAMED00844369026604 EUDAMED00844369026055 EUDAMED
- Basic UDI-DI
- B-00844369026246 EUDAMEDB-00844369026017 EUDAMEDB-00844369026024 EUDAMEDB-00844369026475 EUDAMEDB-00844369026284 EUDAMEDB-00844369026666 EUDAMEDB-00844369026307 EUDAMEDB-00844369026161 EUDAMEDB-00844369026659 EUDAMEDB-00844369026710 EUDAMEDB-00844369026376 EUDAMEDB-00844369026444 EUDAMEDB-00844369026611 EUDAMEDB-00844369026185 EUDAMEDB-00844369026178 EUDAMEDB-00844369026369 EUDAMEDB-00844369026574 EUDAMEDB-00844369026628 EUDAMEDB-00844369026222 EUDAMEDB-00844369026000 EUDAMEDB-00844369026352 EUDAMEDB-00844369026482 EUDAMEDB-00844369026499 EUDAMEDB-00844369026253 EUDAMEDB-00844369026536 EUDAMEDB-00844369026154 EUDAMEDB-00844369026703 EUDAMEDB-00844369026314 EUDAMEDB-00844369026680 EUDAMEDB-00844369026413 EUDAMEDB-00844369026208 EUDAMEDB-00844369026734 EUDAMEDB-00844369026635 EUDAMEDB-00844369026567 EUDAMEDB-00844369026543 EUDAMEDB-00844369026277 EUDAMEDB-00844369026338 EUDAMEDB-00844369026116 EUDAMEDB-00844369026093 EUDAMEDB-00844369026505 EUDAMEDB-00844369026086 EUDAMEDB-00844369026604 EUDAMEDB-00844369026055 EUDAMED
- EMDN Code
- P030102090202 IOLs, APHAKIC, MONOFOCAL, 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
EUDAMEDEUDAMED
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
Softec HDY™ 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-00844369026246 | 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 (43)
- EUDAMED ea404889-88de-4698-9064-d5f029a6d048 61 fields · synced Aug 4, 2026
- EUDAMED 34c274fc-bcd7-48b6-a699-56d99403e318 61 fields · synced May 16, 2026
- EUDAMED 76853fd0-0a69-453d-88cf-c6d0a24bea06 61 fields · synced May 16, 2026
- EUDAMED 01575423-6f44-4009-bf45-638072991d9c 61 fields · synced May 16, 2026
- EUDAMED ba65321d-d206-48c8-a3bf-a7afa56e9324 61 fields · synced May 16, 2026
- EUDAMED 76e5feef-74a4-46c9-a73f-01c7bdbade07 61 fields · synced May 16, 2026
- EUDAMED ad61e414-e239-4491-a6ac-590d52a030d0 61 fields · synced May 16, 2026
- EUDAMED faca379e-3c7b-4865-94b4-bfbd64688995 61 fields · synced May 16, 2026
- EUDAMED cc32964c-0253-4a9e-b800-b97853299056 61 fields · synced May 17, 2026
- EUDAMED e958d4c9-b053-436c-833f-78f0de0b2aa8 61 fields · synced May 17, 2026
- EUDAMED 2c89050c-86d0-41c5-b7eb-0636cfd0ab2b 61 fields · synced May 17, 2026
- EUDAMED e454cf12-3bd4-47ba-a2f9-9ee7f08ea03d 61 fields · synced May 17, 2026
- EUDAMED 8c7506f2-b4dd-44b4-b1b2-85f878a73907 61 fields · synced May 17, 2026
- EUDAMED 49bc14d5-fcbe-4907-8883-4e5ee251e85a 61 fields · synced May 17, 2026
- EUDAMED e7106dc0-1aa0-4a65-865a-d5a64e411b14 61 fields · synced May 17, 2026
- EUDAMED 6810cb9f-cf33-4409-9450-14359f1796d7 61 fields · synced May 17, 2026
- EUDAMED 102840ed-df0c-4066-a02e-c1c4002d640a 61 fields · synced May 17, 2026
- EUDAMED b0d27143-e91b-4110-b1b8-cce8c17d85ad 61 fields · synced May 17, 2026
- EUDAMED 3bea3709-0353-4e41-8a22-46e5b0377a8a 61 fields · synced May 17, 2026
- EUDAMED 2d6eb1fc-974c-4b25-92fa-47f9cea057f1 61 fields · synced May 17, 2026
- EUDAMED 2bbb5312-1dad-4aad-a949-f77edfe9bd5f 61 fields · synced May 17, 2026
- EUDAMED 8944b60b-d3c9-46b3-8c94-1674aae2aa07 61 fields · synced May 17, 2026
- EUDAMED c420a36e-f0e3-4c18-8f16-e5813c175fce 61 fields · synced May 18, 2026
- EUDAMED 7551b2fa-2fac-4ae5-aa66-2562f7677557 61 fields · synced May 18, 2026
- EUDAMED fec46d73-69ad-4b56-acd0-083a5d4e0b97 61 fields · synced May 18, 2026
- EUDAMED c22d3fe8-83de-48da-8818-511621cab15e 61 fields · synced May 19, 2026
- EUDAMED 312b28cd-0530-4bd7-bb1f-a265abf11570 61 fields · synced May 19, 2026
- EUDAMED 9485550e-fb26-4692-8cee-3ebf2a6bedd7 61 fields · synced May 19, 2026
- EUDAMED 85f81643-79eb-42eb-9d0b-46f67b048405 61 fields · synced May 19, 2026
- EUDAMED aca2d3d3-73ba-4004-9eeb-ee316ea104f0 61 fields · synced May 19, 2026
- EUDAMED 0bf518c7-16b1-4bef-830d-806798ccc4ae 61 fields · synced May 19, 2026
- EUDAMED 1d252917-318d-4866-abb9-3590e16a298e 61 fields · synced May 19, 2026
- EUDAMED 5b4840fd-45fa-44a9-853a-3614e9aab987 61 fields · synced May 19, 2026
- EUDAMED 6dd97e91-9860-4bba-a050-e4ace9618d15 61 fields · synced May 19, 2026
- EUDAMED cf5f4e7c-10b1-4530-ba5f-db8f20d7313c 61 fields · synced May 19, 2026
- EUDAMED 7dbd7bf0-2eb1-4d2a-83c6-92740e389498 61 fields · synced May 19, 2026
- EUDAMED 021bd1b9-8880-4597-a043-81ebeef81f24 61 fields · synced May 19, 2026
- EUDAMED 38a51e2e-2d6b-4d8f-ae23-4f4d8e252fd0 61 fields · synced May 19, 2026
- EUDAMED 1b425995-d07e-4711-9e8c-16b01c31bbfc 61 fields · synced May 19, 2026
- EUDAMED 83f7c698-3ced-44c5-9556-d41f10878166 61 fields · synced May 19, 2026
- EUDAMED 43935512-cbae-4c75-9fcb-12e4e8e497eb 61 fields · synced May 19, 2026
- EUDAMED 7b07e81c-6716-4d62-ad3c-1e08145e5664 61 fields · synced May 19, 2026
- EUDAMED 238c28c5-42a8-4962-8569-a627af099c68 61 fields · synced May 19, 2026