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Subretinal injection needle 23G tapered to 38G complete with handpiece
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0468Model Subretinal injection needle / Ago iniezione sub retinale
by Aktive Srl
Identity
- Trade Name
- Subretinal injection needle 23G tapered to 38G complete with handpiece EUDAMEDFDA UDI
- Generic Name
- Ophthalmic working-channel cannula, single-use FDA UDI
- Device Name
- Subretinal injection needle / Ago iniezione sub retinale EUDAMEDSubretinal injection needle 23G tapered to 38G complete with handpiece FDA UDI
- Model / Reference
- Subretinal injection needle / Ago iniezione sub retinale EUDAMEDAK-0468 EUDAMEDFDA UDI
- Description
- Subretinal injection needle 23G tapered to 38G complete with handpiece FDA UDI
Identifiers
- Catalog Number
- AK-0468 FDA UDI
- Primary DI / UDI-DI
- 08052276001627 EUDAMED08052276026743 FDA UDI
- Basic UDI-DI
- 8052276FT0001ID2CA EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Ophthalmic working-channel cannula, 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
Subretinal injection needle 23G tapered to 38G complete with handpiece by Aktive Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8052276FT0001ID2CA | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8052276FT0001ID2CA | 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 bf757100-4d8b-48da-a490-898565608b7f 61 fields · synced May 31, 2026
- FDA UDI 3ab94af1-b1b4-4732-ae71-bfc01cca4296 36 fields · synced May 30, 2026