← Back to catalogue
Scleral blade 25G
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0348/SModel Scleral knife / Lance sclerali
by Aktive Srl
Identity
- Trade Name
- Scleral blade 25G EUDAMEDFDA UDI
- Generic Name
- Ophthalmic knife, single-use FDA UDI
- Device Name
- Scleral knife / Lance sclerali EUDAMEDScleral blade 25G FDA UDI
- Model / Reference
- Scleral knife / Lance sclerali EUDAMEDAK-0348/S EUDAMEDFDA UDI
- Description
- Scleral blade 25G FDA UDI
Identifiers
- Catalog Number
- AK-0348/S FDA UDI
- Primary DI / UDI-DI
- 08052276019592 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0002ID5CP EUDAMED
- Unit of Use DI
- 08052276000422 EUDAMED
- FDA Product Code
- HNN FDA UDI
- EMDN Code
- Q021109 OPHTHALMIC SURGERY SPATULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic knife, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Italy 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Scleral blade 25G by Aktive Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8052276FT0002ID5CP | 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
- Aktive Srl
- EUDAMED SRN
- IT-MF-000007813
Sources (2)
- EUDAMED bf2c9246-4d06-42c0-90a1-26b4f8141fad 61 fields · synced Jul 25, 2026
- FDA UDI fa4da29b-a416-486a-bc83-8e117448bd9a 36 fields · synced May 30, 2026