Identity
- Trade Name
- UBM Probe 4SIGHT EUDAMED
- Device Name
- UBM Probe 4SIGHT EUDAMED
- Model / Reference
- 24-8000U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00897826002314 EUDAMED
- Basic UDI-DI
- B-00897826002314 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UBM Probe 4SIGHT by Accutome Inc. DBA Keeler USA — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: 4Sight system
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00897826002314 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Accutome Inc. DBA Keeler USA
- EUDAMED SRN
- US-MF-000036181
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4d439b77-9b1e-4394-a240-9846ac7a515b 61 fields · synced Jun 19, 2026