Identity
- Trade Name
- RoboTip EUDAMEDSurgilum FDA UDI
- Generic Name
- Corneal marker handpiece tip FDA UDI
- Device Name
- 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. It is a small device preloaded with ink. This is a single-use device. FDA UDI
- Model / Reference
- TPS101 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. It is a small device preloaded with ink. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- TPS101 FDA UDI
- Primary DI / UDI-DI
- B836TPS1011 EUDAMEDB836TPS1010 FDA UDI
- Basic UDI-DI
- B-B836TPS1011 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
RoboTip by Surgilum, LLC — Class I — MDD, 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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-B836TPS1011 | 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 12e8004a-b95c-4eba-ac49-7e420c69e066 61 fields · synced Jul 15, 2026
- FDA UDI 35910010-1980-46ab-977c-375db986d6e8 35 fields · synced May 29, 2026