← Back to catalogue
Charles Cannula Soft Tip 23G, 36mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0513/XLModel Charles Cannulae Tips/Ago Charles
by Aktive Srl
Identity
- Trade Name
- Charles Cannula Soft Tip 23G, 36mm EUDAMEDFDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Charles Cannulae Tips/Ago Charles EUDAMEDCharles Cannula Soft Tip 23G, 36mm FDA UDI
- Model / Reference
- Charles Cannulae Tips/Ago Charles EUDAMEDAK-0513/XL EUDAMEDFDA UDI
- Description
- Charles Cannula Soft Tip 23G, 36mm FDA UDI
Identifiers
- Catalog Number
- AK-0513/XL FDA UDI
- Primary DI / UDI-DI
- 08052276027160 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID1C8 EUDAMED
- Unit of Use DI
- 08056477559512 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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
Charles Cannula Soft Tip 23G, 36mm 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 | 8052276FT0001ID1C8 | 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 a0c9578c-8ea6-4d62-abd1-58696d9d096f 61 fields · synced Jul 8, 2026
- FDA UDI 59afe7fd-89da-4bc1-8bd0-8dcc00372913 36 fields · synced May 30, 2026