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Asqelio Toric Preloaded IOL Delivery System
EUDAMEDClass IIb (EU MDR)
Ref X2TPIO130Y-V3
Identity
- Device Name
- Asqelio Toric Preloaded IOL Delivery System EUDAMED
- Model / Reference
- X2TPIO130Y-V3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00197923554403 EUDAMED
- Basic UDI-DI
- B-00197923554403 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 Preloaded IOL Delivery System 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-00197923554403 | 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 3baa0141-15e3-4e97-ae46-eb957d49c838 61 fields · synced Jun 18, 2026