Identity
- Device Name
- 860UV EUDAMED
- Model / Reference
- 860UV Spheric EUDAMED860UV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814106011330 EUDAMED
- Basic UDI-DI
- B-00814106011330 EUDAMED
- EMDN Code
- P030102090102 IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHILIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Norway 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
860uv by U.S. Iol, 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-00814106011330 | Class IIb | Active |
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Manufacturer
- Manufacturer
- U.S. IOL, Inc.
- EUDAMED SRN
- US-MF-000030660
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0c07b7ba-6e9d-47d3-bd12-b74805b35fd6 61 fields · synced Jul 26, 2026