Identity
- Trade Name
- Infrared RoboTip EUDAMEDSurgilum FDA UDI
- Generic Name
- Corneal marker handpiece tip FDA UDI
- Device Name
- Infrared RoboTip EUDAMEDA sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. this is a single-use device. FDA UDI
- Model / Reference
- IRT101 EUDAMEDFDA UDI
- Description
- A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. this is a single-use device. FDA UDI
Identifiers
- Catalog Number
- IRT101 FDA UDI
- Primary DI / UDI-DI
- B836IRT1011 EUDAMEDB836IRT1010 FDA UDI
- Basic UDI-DI
- B-B836IRT1011 EUDAMED
- FDA Product Code
- HMR FDA UDI
- EMDN Code
- Q020203 CORNEAL MARKERS EUDAMED
- GMDN Term
- Corneal marker handpiece tip FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4570 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Corneal marker, reusable
Infrared RoboTip by Surgilum, LLC — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-B836IRT1011 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Surgilum, LLC
- EUDAMED SRN
- US-MF-000018440
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 75fdc418-962c-40dd-bc01-d70a8eca2958 61 fields · synced Jul 11, 2026
- FDA UDI c5c66de5-c181-44e7-b4be-73c9e9c1afad 34 fields · synced May 30, 2026