Identity
- Trade Name
- RoboMarker EUDAMEDSurgilum FDA UDI
- Generic Name
- Corneal marker handpiece FDA UDI
- Device Name
- RoboMarker EUDAMEDA manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it includes a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device. FDA UDI
- Model / Reference
- RMS101 EUDAMEDFDA UDI
- Description
- A manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it includes a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- RMS101 FDA UDI
- Primary DI / UDI-DI
- +B836RMS1010 EUDAMEDB836RMS1010 FDA UDI
- Basic UDI-DI
- ++B836RMS101YJ EUDAMED
- Direct Marketing DI
- +B836RMS1010 EUDAMED
- FDA Product Code
- HMR FDA UDI
- EMDN Code
- Q020203 CORNEAL MARKERS EUDAMED
- GMDN Term
- Corneal marker handpiece 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
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
Category: Corneal marker, reusable
RoboMarker by Surgilum, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Corneal marker, reusable.
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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 | ++B836RMS101YJ | 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 6798e655-fc87-495c-bc92-d0d3d122f0c2 61 fields · synced Jul 10, 2026
- FDA UDI 11b2a96f-9c0c-4ed1-bfe6-de8059184a50 34 fields · synced May 30, 2026