Identity
- Trade Name
- HASA OPTIX EUDAMEDSterile, Single Use, Speculum Adjustable Fine Full Blades FDA UDI
- Generic Name
- Eyelid speculum, single-use FDA UDI
- Device Name
- 655038x10: Sterile, Single Use, Speculum Adjustable Fine Full Blades, L 65mm EUDAMED
- Model / Reference
- 655038 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05404027427584 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05404027427584 EUDAMED
- FDA Product Code
- HNC FDA UDI
- EMDN Code
- Q021106 OPHTHALMIC SURGERY DILATORS, SINGLE-USE EUDAMED
- GMDN Term
- Eyelid speculum, 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
Hasa Optix by Hasa Optix — 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-05404027427584 | 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 61827f5d-4c6d-45c4-abd2-3544d48e2cce 61 fields · synced Jun 20, 2026
- FDA UDI 5b0593f1-a538-4c5c-b6ae-5c054b2ecf0e 34 fields · synced May 30, 2026