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Asqelio™ Trifcoal Toric Preloaded IOL Delivery System
EUDAMEDClass IIb (EU MDR)
Ref X2TTPIO130C-V3
Identity
- Device Name
- Asqelio™ Trifcoal Toric Preloaded IOL Delivery System EUDAMED
- Model / Reference
- X2TTPIO130C-V3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00197923699463 EUDAMED
- Basic UDI-DI
- B-00197923699463 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
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™ Trifcoal 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-00197923699463 | 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 669e5e96-6509-4061-92bf-f67ee4041b09 61 fields · synced Aug 1, 2026