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Asqelio Pluris Toric Soft Hydrophobic Intraocular Lens
EUDAMEDClass IIb (EU MDR)
Ref UTLIO130Y
Identity
- Device Name
- Asqelio Pluris Toric Soft Hydrophobic Intraocular Lens EUDAMED
- Model / Reference
- UTLIO130Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00197923481945 EUDAMED
- Basic UDI-DI
- B-00197923481945 EUDAMED
- EMDN Code
- P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Asqelio Pluris Toric Soft Hydrophobic Intraocular Lens by AST VisionCare 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-00197923481945 | Class IIb | Active |
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Manufacturer
- Manufacturer
- AST VisionCare Inc.
- EUDAMED SRN
- US-MF-000021852
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 8ad8ddde-62e5-4fab-9a7e-7fbc8c9b1166 61 fields · synced Jun 19, 2026