Identity
- Trade Name
- RxSight Insertion Device FDA UDI
- Generic Name
- Manual intraocular lens injector, single-use FDA UDI
- Device Name
- Injector for ophthalmological use EUDAMEDRxSight Insertion Device (Single-Use) FDA UDI
- Model / Reference
- 63002 EUDAMEDFDA UDI
- Description
- RxSight Insertion Device (Single-Use) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818806021019 EUDAMED10818806021016 FDA UDI
- Basic UDI-DI
- 0818806020038K EUDAMED
- 510(k) Number
- K231838 FDA UDI
- FDA Product Code
- MSS FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Manual intraocular lens injector, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Injector for ophthalmological use by Rxsight, Inc. — Class IIa — 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 | 0818806020038K | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RxSight, Inc.
- EUDAMED SRN
- US-MF-000010449
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED e0366fef-8893-42c2-8cff-62a2373efbd9 61 fields · synced Jul 23, 2026
- FDA UDI cbf09047-e9c2-47f0-8fe7-7b372e913776 35 fields · synced May 30, 2026