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Asqelio PairedFocus Toric Soft Hydrophobic Intraocular Lens
EUDAMEDClass IIb (EU MDR)
Ref PFTLIO130Y
Identity
- Device Name
- Asqelio PairedFocus Toric Soft Hydrophobic Intraocular Lens EUDAMED
- Model / Reference
- PFTLIO130Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00197923422917 EUDAMED
- Basic UDI-DI
- B-00197923422917 EUDAMED
- EMDN Code
- P030102100301 IOLs, APHAKIC, MULTIFOCAL, 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
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
Asqelio PairedFocus 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-00197923422917 | 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 915e7085-d99c-44cd-8857-82cc8a7791de 61 fields · synced Jun 19, 2026