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Trocar set 20G with removable valve
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0349/NModel Trocar
by Aktive Srl
Identity
- Trade Name
- Trocar set 20G with removable valve EUDAMEDFDA UDI
- Generic Name
- Ophthalmic working-channel cannula, single-use FDA UDI
- Device Name
- Trocar EUDAMEDTrocar set 20G with removable valve FDA UDI
- Model / Reference
- Trocar EUDAMEDAK-0349/N EUDAMEDFDA UDI
- Description
- Trocar set 20G with removable valve FDA UDI
Identifiers
- Catalog Number
- AK-0349/N FDA UDI
- Primary DI / UDI-DI
- 08052276019608 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID14KV EUDAMED
- Unit of Use DI
- 08056477558546 EUDAMED
- FDA Product Code
- NGY 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
Trocar set 20G with removable valve 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 | 8052276FT0001ID14KV | 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 2bd82380-ae7a-4a58-a116-b518f6086eb5 61 fields · synced Jul 9, 2026
- FDA UDI f2e12b67-4c69-4715-9982-0373cdbcfa5c 36 fields · synced May 29, 2026