Identity
- Trade Name
- RxSight Contact Lens FDA UDI
- Generic Name
- Vitrectomy contact lens, reusable FDA UDI
- Device Name
- RxSight Contact Lens EUDAMEDFDA UDI
- Model / Reference
- 62020-002 EUDAMEDFDA UDI
- Description
- RxSight Contact Lens FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818806021774 EUDAMEDFDA UDI
- Basic UDI-DI
- 0818806020058P EUDAMED
- FDA Product Code
- HJK FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Vitrectomy contact lens, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1385 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
RxSight Contact Lens by Rxsight, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201909 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0818806020058P | Class I | Active |
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Manufacturer
- Manufacturer
- RxSight, Inc.
- EUDAMED SRN
- US-MF-000010449
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED f81af8e5-81cc-4562-92d3-f076d44d8a51 61 fields · synced Jul 24, 2026
- FDA UDI 5d95aa1b-66dc-45ec-b15d-0f0b12feecd8 33 fields · synced May 30, 2026
- FDA 510(k) K201909 1 fields · synced May 18, 2026