Identity
- Trade Name
- Softec HD3™ EUDAMED
- Device Name
- Softec HD3 EUDAMEDSoftec HD3™ EUDAMED
- Model / Reference
- Softec HD3™ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844369004565 EUDAMED00844369004473 EUDAMED00844369004602 EUDAMED00844369004657 EUDAMED00844369004220 EUDAMED00844369004749 EUDAMED00844369004527 EUDAMED00844369004596 EUDAMED00844369004633 EUDAMED00844369004626 EUDAMED00844369004664 EUDAMED00844369004183 EUDAMED00844369004732 EUDAMED00844369004442 EUDAMED00844369004350 EUDAMED00844369004510 EUDAMED00844369004701 EUDAMED00844369004367 EUDAMED00844369004381 EUDAMED00844369004329 EUDAMED00844369004275 EUDAMED00844369004572 EUDAMED00844369004541 EUDAMED00844369004145 EUDAMED00844369004497 EUDAMED00844369004282 EUDAMED00844369004695 EUDAMED00844369004619 EUDAMED00844369004343 EUDAMED00844369004688 EUDAMED00844369004398 EUDAMED00844369004466 EUDAMED
- Basic UDI-DI
- B-00844369004565 EUDAMEDB-00844369004473 EUDAMEDB-00844369004602 EUDAMEDB-00844369004657 EUDAMEDB-00844369004220 EUDAMEDB-00844369004749 EUDAMEDB-00844369004527 EUDAMEDB-00844369004596 EUDAMEDB-00844369004633 EUDAMEDB-00844369004626 EUDAMEDB-00844369004664 EUDAMEDB-00844369004183 EUDAMEDB-00844369004732 EUDAMEDB-00844369004442 EUDAMEDB-00844369004350 EUDAMEDB-00844369004510 EUDAMEDB-00844369004701 EUDAMEDB-00844369004367 EUDAMEDB-00844369004381 EUDAMEDB-00844369004329 EUDAMEDB-00844369004275 EUDAMEDB-00844369004572 EUDAMEDB-00844369004541 EUDAMEDB-00844369004145 EUDAMEDB-00844369004497 EUDAMEDB-00844369004282 EUDAMEDB-00844369004695 EUDAMEDB-00844369004619 EUDAMEDB-00844369004343 EUDAMEDB-00844369004688 EUDAMEDB-00844369004398 EUDAMEDB-00844369004466 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
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
Softec HD3™ 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-00844369004565 | 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 (32)
- EUDAMED 0c3e2510-4c29-40cb-a178-6c8265e6d767 61 fields · synced Sep 17, 2026
- EUDAMED bbe990f7-e50a-4655-886f-43260ff2cb06 61 fields · synced May 16, 2026
- EUDAMED cf061439-f946-4bae-b8ba-89ec2581f6bc 61 fields · synced May 16, 2026
- EUDAMED 9e3207dc-4581-41b7-a888-651511cdb49f 61 fields · synced May 16, 2026
- EUDAMED 8df44296-3d88-4b10-80ed-3bc38f647963 61 fields · synced May 17, 2026
- EUDAMED e4378afc-3572-4817-9e9f-b82542961800 61 fields · synced May 17, 2026
- EUDAMED e8714185-e3e1-43c1-b45b-a30fcdc4f863 61 fields · synced May 17, 2026
- EUDAMED 9eff9d0e-809d-487e-8f9b-f132234963fc 61 fields · synced May 17, 2026
- EUDAMED 6ef94603-c45d-46e7-a33f-6b0df914a862 61 fields · synced May 17, 2026
- EUDAMED 270688fc-7518-40b4-836c-fae3ca70e27b 61 fields · synced May 17, 2026
- EUDAMED 77f31ff2-c693-4714-b6b6-2a49d81abaa5 61 fields · synced May 17, 2026
- EUDAMED f8b0dd08-0dfd-4a1a-b5a3-f7f9570684e5 61 fields · synced May 17, 2026
- EUDAMED e7e223a9-316d-4b24-959a-601a76be0bc2 61 fields · synced May 17, 2026
- EUDAMED bb48c6cc-8ae9-4299-ba68-023749d6c26c 61 fields · synced May 17, 2026
- EUDAMED 03669869-fd65-4f78-b163-3e394776a31d 61 fields · synced May 17, 2026
- EUDAMED 6c3882d1-cfe2-4e5a-bd41-e6434704068c 61 fields · synced May 18, 2026
- EUDAMED 2e81072f-b578-4152-b2d0-cec7c27c260a 61 fields · synced May 18, 2026
- EUDAMED 4a7fd1ae-0636-44fd-b32d-612ed2df038b 61 fields · synced May 19, 2026
- EUDAMED 9e0864eb-489a-4cda-9d1d-f0d3a8e53d51 61 fields · synced May 19, 2026
- EUDAMED b033df42-799e-44fb-ad9b-129095cebda9 61 fields · synced May 19, 2026
- EUDAMED ec78c32d-917e-4a8d-b140-b0c71a9c2385 61 fields · synced May 19, 2026
- EUDAMED 1c40417d-b33d-42bd-b0ce-f9bc738bf167 61 fields · synced May 19, 2026
- EUDAMED daf3af83-5936-4a83-bf6e-c0bf36e422ae 61 fields · synced May 19, 2026
- EUDAMED 57ec1481-65c5-485d-ad6e-d0d5271a38c7 61 fields · synced May 19, 2026
- EUDAMED 8c6c461b-e35d-4097-a3f5-f7c5613b0e79 61 fields · synced May 19, 2026
- EUDAMED a223a219-1339-45a9-89d5-3bf271f95166 61 fields · synced May 19, 2026
- EUDAMED 36e1aa60-377f-4221-953f-0535e58592b9 61 fields · synced May 19, 2026
- EUDAMED f9a53e6e-ae25-455f-9af9-f4351c29636b 61 fields · synced May 19, 2026
- EUDAMED 4d369c11-1d53-4c89-b346-16610077d7a8 61 fields · synced May 19, 2026
- EUDAMED 93467cb3-aebb-415d-87c9-4b18f10a2a8d 61 fields · synced May 19, 2026
- EUDAMED 54e498c4-1a19-4905-970c-c69aa36b345f 61 fields · synced May 19, 2026
- EUDAMED 9fc99019-bbc6-46dd-9326-2c7640c2d720 61 fields · synced May 19, 2026