Identity
- Trade Name
- B-Scan Probe 4SIGHT EUDAMED
- Device Name
- B-Scan Probe 4SIGHT EUDAMED
- Model / Reference
- 24-8000B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00897826002123 EUDAMED
- Basic UDI-DI
- B-00897826002123 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
B-Scan 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-00897826002123 | 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 b1567350-1053-44e2-af77-627e5842b212 61 fields · synced Jun 18, 2026