Identity
- Trade Name
- HASA OPTIX EUDAMEDSterile,Single Use,Vannas Scissors,Curved,Sharp Pointed Tips FDA UDI
- Generic Name
- Intraocular scissors, conventional-hinge, single-use FDA UDI
- Device Name
- 553014: Sterile, Single Use, Vannas Scissors, Curved, Sharp Pointed Tips, Tip To Pivot Length 9.5mm, 82mm EUDAMED
- Model / Reference
- 553014 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05404027410333 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05404027410333 EUDAMED
- FDA Product Code
- HNF FDA UDI
- EMDN Code
- Q021103 OPHTHALMIC SURGERY SCISSORS, SINGLE-USE EUDAMED
- GMDN Term
- Intraocular scissors, conventional-hinge, 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-05404027410333 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (2)
- EUDAMED 6b016d1f-54a5-4148-8fc9-00301d56d8b1 61 fields · synced Jun 8, 2026
- FDA UDI 83ca9dff-0a79-4b65-ac7c-d1daa9fe0a7d 34 fields · synced May 29, 2026