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Asqelio™ Toric Soft Hydrophobic Intraocular Lens
EUDAMEDClass IIb (EU MDR)
Ref TLIO130Y
Identity
- Device Name
- Asqelio™ Toric Soft Hydrophobic Intraocular Lens EUDAMED
- Model / Reference
- TLIO130Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840149804455 EUDAMED
- Basic UDI-DI
- B-00840149804455 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™ 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-00840149804455 | 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 169d8bdc-240e-41a6-8592-fe9f4b0cf972 61 fields · synced Jun 18, 2026