Identity
- Trade Name
- ASTREA™ EUDAMEDAstrea™ Click EUDAMED
- Device Name
- ASTREA EUDAMEDAstrea Click EUDAMED
- Model / Reference
- ASTREA™ EUDAMEDAstrea™ Click EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844369004954 EUDAMED00844369008839 EUDAMED
- Basic UDI-DI
- B-00844369004954 EUDAMEDB-00844369008839 EUDAMED
- EMDN Code
- P030102100202 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia 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
Astrea™ 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-00844369004954 | Class IIb | Active |
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 (2)
- EUDAMED e5af1957-bc99-476d-8ab7-5a0d780f380f 61 fields · synced Sep 17, 2026
- EUDAMED 0da3a0d1-bd7c-45d4-b80a-190becdf4f52 61 fields · synced May 18, 2026