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Full Handle Backflush 20G Soft tip Active/Passive
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0452/APModel Backflush Active/Passive_Backflush Attivo/Passivo
by Aktive Srl
Identity
- Trade Name
- Full Handle Backflush 20G Soft tip Active/Passive EUDAMEDFDA UDI
- Generic Name
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
- Device Name
- Backflush Active/Passive_Backflush Attivo/Passivo EUDAMEDFull Handle Backflush 20G Soft tip Active/Passive FDA UDI
- Model / Reference
- Backflush Active/Passive_Backflush Attivo/Passivo EUDAMEDAK-0452/AP EUDAMEDFDA UDI
- Description
- Full Handle Backflush 20G Soft tip Active/Passive FDA UDI
Identifiers
- Catalog Number
- AK-0452/AP FDA UDI
- Primary DI / UDI-DI
- 08052276026408 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID3CC EUDAMED
- Unit of Use DI
- 08056477557389 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 20G Soft tip Active/Passive 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 | 8052276FT0001ID3CC | 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 d598e279-2865-4b99-9aed-a7f3772d7b4e 61 fields · synced Jul 22, 2026
- FDA UDI 5e863162-c5ce-4e2b-b61d-a0d50fd144e8 36 fields · synced May 29, 2026