Identity
- Trade Name
- Tetraflex™ HD EUDAMED
- Device Name
- Tetraflex HD EUDAMED
- Model / Reference
- Tetraflex™ HD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844369030694 EUDAMED
- Basic UDI-DI
- B-00844369030694 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
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
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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00844369030694 | 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 (1)
- EUDAMED 28a2677f-ebc2-49f0-84f5-8f051b25ac42 61 fields · synced Jun 19, 2026