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High pressure injection/aspiration system for syringe - Connector D
EUDAMEDFDA UDIClass I (EU MDR)
Ref AK-0383/D2Model High pressure injection/aspiration system - Sistema di Iniezione/Aspirazione ad alta pressione
by Aktive Srl
Identity
- Trade Name
- High pressure injection/aspiration system for syringe - Connector D EUDAMEDFDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- High pressure injection/aspiration system - Sistema di Iniezione/Aspirazione ad alta pressione EUDAMEDHigh pressure injection/aspiration system for syringe - Connector D FDA UDI
- Model / Reference
- High pressure injection/aspiration system - Sistema di Iniezione/Aspirazione ad alta pressione EUDAMEDAK-0383/D2 EUDAMEDFDA UDI
- Description
- High pressure injection/aspiration system for syringe - Connector D FDA UDI
Identifiers
- Catalog Number
- AK-0383/D2 FDA UDI
- Primary DI / UDI-DI
- 08052276019790 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID13KT EUDAMED
- Unit of Use DI
- 08058340226262 EUDAMED
- FDA Product Code
- KYG FDA UDI
- EMDN Code
- Q021199 OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
High pressure injection/aspiration system for syringe - Connector D by Aktive Srl — Class I — 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 | 8052276FT0001ID13KT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aktive Srl
- EUDAMED SRN
- IT-MF-000007813
Sources (2)
- EUDAMED 9abb2417-6509-4227-a6d5-d65d22792f45 61 fields · synced Jul 9, 2026
- FDA UDI 375f1961-c986-4dd1-9f07-0a06f7b85a95 35 fields · synced May 30, 2026