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Active Reservoir
EUDAMEDFDA UDIClass I (EU MDR)
Ref AK-0441Model ACTIVE RESERVOIR / SERBATOIO BACKFLUSH ATTIVO
by Aktive Srl
Identity
- Trade Name
- Active Reservoir EUDAMEDFDA UDI
- Generic Name
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
- Device Name
- ACTIVE RESERVOIR / SERBATOIO BACKFLUSH ATTIVO EUDAMEDActive Reservoir FDA UDI
- Model / Reference
- ACTIVE RESERVOIR / SERBATOIO BACKFLUSH ATTIVO EUDAMEDAK-0441 EUDAMEDFDA UDI
- Description
- Active Reservoir FDA UDI
Identifiers
- Catalog Number
- AK-0441 FDA UDI
- Primary DI / UDI-DI
- 08052276026385 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID5CG EUDAMED
- Unit of Use DI
- 08058340220741 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 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
Active Reservoir by Aktive Srl — Class I — 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 | 8052276FT0001ID5CG | 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 9cd65a91-140f-4d08-b0d8-d5d70fd1d9eb 61 fields · synced Jun 18, 2026
- FDA UDI 0db5a00a-981d-4224-9a37-20c3f76ed2c5 36 fields · synced May 30, 2026