Identity
- Trade Name
- 4Sight EUDAMEDFDA UDI
- Generic Name
- Ultrasound pachymeter FDA UDI
- Device Name
- 4Sight EUDAMED
- Model / Reference
- 24-8000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 24-8000 FDA UDI
- Primary DI / UDI-DI
- 00897826002079 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00897826002079 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ultrasound pachymeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Türkiye 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
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
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
4Sight by Accutome Inc. DBA Keeler USA — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Manufacturer's product page: 4Sight system
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 | K152573 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00897826002079 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Accutome Inc. DBA Keeler USA
- EUDAMED SRN
- US-MF-000036181
- FDA Applicant
- Accutome, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 4217d908-ef94-4be8-8c19-4e4d708ac837 85 fields · synced Jun 18, 2026
- FDA UDI bb04a165-fb4b-4388-ba38-4e26bf452452 33 fields · synced May 30, 2026
- FDA 510(k) K152573 1 fields · synced May 18, 2026