Identity
- Trade Name
- B-Scan Plus EUDAMEDFDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Device Name
- B-Scan Plus EUDAMED
- Model / Reference
- 24-6100 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 24-6100 FDA UDI
- Primary DI / UDI-DI
- 00897826002031 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00897826002031 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Germany 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
B-Scan Plus by Accutome Inc. DBA Keeler USA — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00897826002031 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED a221c12b-d877-468c-9fe0-448d2f4685ac 61 fields · synced Jul 17, 2026
- FDA UDI a4b0888d-b5ca-44af-83b7-e8fa520e071d 33 fields · synced May 30, 2026