← Back to catalogue

Tetraflex™ HD

EUDAMED

Class IIb (EU MDR)

Ref Tetraflex™ HD

by Lenstec (Barbados) Inc.

Identity

Trade Name
Tetraflex™ HD EUDAMED
Device Name
Tetraflex HD EUDAMED
Tetraflex™ HD EUDAMED
Model / Reference
Tetraflex™ HD EUDAMED

Identifiers

Primary DI / UDI-DI
00844369030502 EUDAMED
00844369030458 EUDAMED
00844369030625 EUDAMED
00844369030113 EUDAMED
00844369030649 EUDAMED
00844369030557 EUDAMED
00844369030366 EUDAMED
00844369030212 EUDAMED
00844369030755 EUDAMED
00844369030137 EUDAMED
00844369030540 EUDAMED
00844369030403 EUDAMED
00844369030373 EUDAMED
00844369030519 EUDAMED
00844369030298 EUDAMED
00844369030359 EUDAMED
00844369030724 EUDAMED
00844369030250 EUDAMED
00844369030144 EUDAMED
00844369030175 EUDAMED
00844369030618 EUDAMED
00844369030465 EUDAMED
00844369030014 EUDAMED
00844369030700 EUDAMED
00844369030076 EUDAMED
00844369030588 EUDAMED
00844369030472 EUDAMED
00844369030236 EUDAMED
00844369030151 EUDAMED
00844369030106 EUDAMED
00844369030199 EUDAMED
00844369030656 EUDAMED
00844369030069 EUDAMED
00844369030779 EUDAMED
Basic UDI-DI
B-00844369030502 EUDAMED
B-00844369030458 EUDAMED
B-00844369030625 EUDAMED
B-00844369030113 EUDAMED
B-00844369030649 EUDAMED
B-00844369030557 EUDAMED
B-00844369030366 EUDAMED
B-00844369030212 EUDAMED
B-00844369030755 EUDAMED
B-00844369030137 EUDAMED
B-00844369030540 EUDAMED
B-00844369030403 EUDAMED
B-00844369030373 EUDAMED
B-00844369030519 EUDAMED
B-00844369030298 EUDAMED
B-00844369030359 EUDAMED
B-00844369030724 EUDAMED
B-00844369030250 EUDAMED
B-00844369030144 EUDAMED
B-00844369030175 EUDAMED
B-00844369030618 EUDAMED
B-00844369030465 EUDAMED
B-00844369030014 EUDAMED
B-00844369030700 EUDAMED
B-00844369030076 EUDAMED
B-00844369030588 EUDAMED
B-00844369030472 EUDAMED
B-00844369030236 EUDAMED
B-00844369030151 EUDAMED
B-00844369030106 EUDAMED
B-00844369030199 EUDAMED
B-00844369030656 EUDAMED
B-00844369030069 EUDAMED
B-00844369030779 EUDAMED
EMDN Code
P030102110202 IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Czechia EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMEDEUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDEUDAMED

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

Tetraflex™ HD 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Lenstec (Barbados) Inc.
EUDAMED SRN
BB-MF-000019262
Authorised Representative
CMI spol. s r.o. SK-AR-000007425

Sources (34)

  • EUDAMED e04b2769-2e07-4bd1-8d10-750c7762993c 61 fields · synced Sep 18, 2026
  • EUDAMED 1bb52002-519a-4279-945c-eb8d25378b17 61 fields · synced May 16, 2026
  • EUDAMED 25b62b7e-9a32-47ea-be47-b5c12fa784bc 61 fields · synced May 16, 2026
  • EUDAMED 4eed3a53-0d88-4179-aa06-0732659e19f9 61 fields · synced May 16, 2026
  • EUDAMED 5b21f5af-561e-4d43-a1dd-b362414acbf0 61 fields · synced May 16, 2026
  • EUDAMED 05057f05-2b6b-42fd-ac7e-67a509e71f21 61 fields · synced May 17, 2026
  • EUDAMED 46bfd2d8-16f9-4409-afbd-2d43cbb70f66 61 fields · synced May 17, 2026
  • EUDAMED 86db4eef-e3dc-4e0a-9139-83975ec5b8d6 61 fields · synced May 17, 2026
  • EUDAMED 3deffbf6-4d68-47c9-a97a-59d8c915e62f 61 fields · synced May 17, 2026
  • EUDAMED 190091f7-c56f-4fe3-92e5-8c5784f91df2 61 fields · synced May 17, 2026
  • EUDAMED 31d99c35-16df-4646-8636-aab7ec70011d 61 fields · synced May 17, 2026
  • EUDAMED 94c119df-aa39-486f-a062-ff287f15c5d6 61 fields · synced May 17, 2026
  • EUDAMED ce7bb557-37f8-4654-9b05-76ef21bee78a 61 fields · synced May 17, 2026
  • EUDAMED 359f97c6-a230-4aa1-b8e1-f49a5eb085ad 61 fields · synced May 17, 2026
  • EUDAMED e754c43d-bceb-415f-902c-d88353fdf1a4 61 fields · synced May 19, 2026
  • EUDAMED 9a725a08-b336-4942-a73a-fe3d965b0309 61 fields · synced May 19, 2026
  • EUDAMED 0c181f37-9ee2-4d41-9505-8318c0f6ad38 61 fields · synced May 19, 2026
  • EUDAMED 1eec6bf4-288d-443b-be20-124ec9d562da 61 fields · synced May 19, 2026
  • EUDAMED 47ef1503-f146-4fea-8d52-c68ec6914d8f 61 fields · synced May 19, 2026
  • EUDAMED 65e48798-773a-4de0-b687-48d368035be7 61 fields · synced May 19, 2026
  • EUDAMED 2a5c5bfa-eadb-44af-9fa5-2908d07c581a 61 fields · synced May 19, 2026
  • EUDAMED 3ce3fb7f-774f-4b49-9f3e-eb3d1d21cacc 61 fields · synced May 19, 2026
  • EUDAMED 24134a9d-8190-4ff5-a5d1-bdef81e59027 61 fields · synced May 19, 2026
  • EUDAMED c6b46c51-3514-40d8-a5ca-28ef4a169afd 61 fields · synced May 19, 2026
  • EUDAMED 07af11be-eb97-450a-b7d1-7fa57ece7b70 61 fields · synced May 19, 2026
  • EUDAMED 60b6bd04-d3dd-4426-a8da-60e8f2b8c70a 61 fields · synced May 19, 2026
  • EUDAMED f32041ef-2aa8-4611-b34b-839df2d86139 61 fields · synced May 19, 2026
  • EUDAMED 11c51fef-f551-44d9-9133-026e0577745d 61 fields · synced May 19, 2026
  • EUDAMED 3cfe8ba7-1eac-4f9e-bd7f-237a4726af48 61 fields · synced May 19, 2026
  • EUDAMED 6ed7421d-8db1-43a4-9d3a-6c90e11241d3 61 fields · synced May 19, 2026
  • EUDAMED 637c8672-c84a-443f-8a8f-603699d94476 61 fields · synced May 19, 2026
  • EUDAMED 293191fb-602e-44bc-9859-f7c6669ad6b9 61 fields · synced May 19, 2026
  • EUDAMED d79893aa-f989-4bcf-aa11-08ac8641b357 61 fields · synced May 19, 2026
  • EUDAMED 0b4c80cd-156a-4742-94c2-7d1ef4ed1f62 61 fields · synced May 19, 2026