Identity
- Trade Name
- UBM Plus Guarded EUDAMED
- Device Name
- UBM Plus Guarded EUDAMED
- Model / Reference
- 24-6300-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00897826002352 EUDAMED
- Basic UDI-DI
- B-00897826002352 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Plus Guarded by Accutome Inc. DBA Keeler USA — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103471 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00897826002352 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accutome Inc. DBA Keeler USA
- EUDAMED SRN
- US-MF-000036181
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e1220c9d-f107-4679-9604-02468e1b3b29 61 fields · synced Jul 10, 2026
- FDA 510(k) K103471 1 fields · synced May 18, 2026