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Eight plastic frames with corrective lenses for Magic Leap 2 smart glasses
EUDAMEDClass I (EU MDR)
Ref Lens Kit for Magic Leap 2
Identity
- Device Name
- Eight plastic frames with corrective lenses for Magic Leap 2 smart glasses EUDAMED
- Model / Reference
- Lens Kit for Magic Leap 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860010085608 EUDAMED
- Basic UDI-DI
- 0860010085615PU EUDAMED
- EMDN Code
- Q0210010199 ORGANIC OPHTHALMIC LENSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Eight plastic frames with corrective lenses for Magic Leap 2 smart glasses by Vision Associates of Rochester, Inc. — Class I — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0860010085615PU | Class I | Active |
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Manufacturer
- Manufacturer
- Vision Associates of Rochester, Inc.
- EUDAMED SRN
- US-MF-000038535
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (1)
- EUDAMED bf458ee7-3858-4619-8793-519a4facd2af 61 fields · synced Oct 6, 2026