Identity
- Trade Name
- UV Spectacle Kit with Readers FDA UDI
- Generic Name
- Tinted non-prescription spectacle lens FDA UDI
- Device Name
- Post Op Eyewear EUDAMEDUV Spectacle Kit with Readers FDA UDI
- Model / Reference
- 62022 EUDAMEDFDA UDI
- Description
- UV Spectacle Kit with Readers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818806020876 EUDAMEDFDA UDI
- Basic UDI-DI
- 0818806020048M EUDAMED
- FDA Product Code
- HQY FDA UDI
- EMDN Code
- Y210336 OCCLUSION AND ANTI-RADIATION FILTERS EUDAMED
- GMDN Term
- Tinted non-prescription spectacle lens FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.5850 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Post Op Eyewear by Rxsight, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0818806020048M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- RxSight, Inc.
- EUDAMED SRN
- US-MF-000010449
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED bb373568-91c4-4421-8821-2d54d663a52c 61 fields · synced Jul 21, 2026
- FDA UDI 7906b523-64bd-4ba7-9bfc-fdcd3348ddb5 33 fields · synced May 30, 2026