Identity
- Trade Name
- HASA OPTIX EUDAMEDSterile, Single Use, Manipulator Sinskey 1, 1mm Altitude, Tip 0, 2mm, 110mm FDA UDI
- Generic Name
- Ophthalmic curette, single-use FDA UDI
- Device Name
- 654121x10: Sterile, Single Use, Manipulator Sinskey 1, 1mm Altitude, Tip 0, 2mm, 110mm EUDAMED
- Model / Reference
- 654121 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05404027421865 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05404027421865 EUDAMED
- FDA Product Code
- HND FDA UDI
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic curette, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic surgical probe, single-use
Hasa Optix by Hasa Optix — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-05404027421865 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (2)
- EUDAMED 8c1b246b-3ead-43f3-b727-14a41d42c811 61 fields · synced Jul 18, 2026
- FDA UDI 251e7865-9101-42be-b89f-58d5035316d2 34 fields · synced May 30, 2026