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Full Handle Backflush 25G Soft tip Extensible Active/Passive
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0458/AP-EXModel Backflush Attive/Passive Extensible_Backflush attivo/passivo Estensibile
by Aktive Srl
Identity
- Trade Name
- Full Handle Backflush 25G Soft tip Extensible Active/Passive EUDAMEDFDA UDI
- Generic Name
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
- Device Name
- Backflush Attive/Passive Extensible_Backflush attivo/passivo Estensibile EUDAMEDFull Handle Backflush 25G Soft tip Extensible Active/Passive FDA UDI
- Model / Reference
- Backflush Attive/Passive Extensible_Backflush attivo/passivo Estensibile EUDAMEDAK-0458/AP-EX EUDAMEDFDA UDI
- Description
- Full Handle Backflush 25G Soft tip Extensible Active/Passive FDA UDI
Identifiers
- Catalog Number
- AK-0458/AP-EX FDA UDI
- Primary DI / UDI-DI
- 08052276026538 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID4CE EUDAMED
- Unit of Use DI
- 08052276015822 EUDAMED
- FDA Product Code
- KYG FDA UDI
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4360 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
Full Handle Backflush 25G Soft tip Extensible Active/Passive by Aktive Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 8052276FT0001ID4CE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aktive Srl
- EUDAMED SRN
- IT-MF-000007813
Sources (2)
- EUDAMED d6cac76a-4c54-45d6-a987-33fbad2c87e9 61 fields · synced Jun 18, 2026
- FDA UDI 863efb85-c838-4ed6-88cf-e6867a1c712b 36 fields · synced May 30, 2026