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Passive Reservoir
EUDAMEDFDA UDIClass I (EU MDR)
Ref AK-0440Model PASSIVE RESERVOIR / SERBATOIO BACKFLUSH PASSIVO
by Aktive Srl
Identity
- Trade Name
- Passive Reservoir EUDAMEDFDA UDI
- Generic Name
- Vitrectomy fluid/gas handling handpiece/cannula FDA UDI
- Device Name
- PASSIVE RESERVOIR / SERBATOIO BACKFLUSH PASSIVO EUDAMEDPassive Reservoir FDA UDI
- Model / Reference
- PASSIVE RESERVOIR / SERBATOIO BACKFLUSH PASSIVO EUDAMEDAK-0440 EUDAMEDFDA UDI
- Description
- Passive Reservoir FDA UDI
Identifiers
- Catalog Number
- AK-0440 FDA UDI
- Primary DI / UDI-DI
- 08052276026378 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID6CJ EUDAMED
- Unit of Use DI
- 08058340220734 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
Passive 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 | 8052276FT0001ID6CJ | 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 b52755e8-290a-445d-8b1a-ac74cd509a28 61 fields · synced Jul 9, 2026
- FDA UDI 6de2b943-c5b4-4557-8a0f-4457b9074d85 36 fields · synced May 29, 2026