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Set of 5 Iris Retractors
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0492Model Iris Retractors/Retrattori Iridei
by Aktive Srl
Identity
- Trade Name
- Set of 5 Iris Retractors EUDAMEDFDA UDI
- Generic Name
- Intraocular retractor, single-use FDA UDI
- Device Name
- Iris Retractors/Retrattori Iridei EUDAMEDSet of 5 Iris Retractors FDA UDI
- Model / Reference
- Iris Retractors/Retrattori Iridei EUDAMEDAK-0492 EUDAMEDFDA UDI
- Description
- Set of 5 Iris Retractors FDA UDI
Identifiers
- Catalog Number
- AK-0492 FDA UDI
- Primary DI / UDI-DI
- 08052276027061 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0002ID8CV EUDAMED
- Unit of Use DI
- 08056477550502 EUDAMED
- FDA Product Code
- HOC FDA UDI
- EMDN Code
- Q021107 OPHTHALMIC SURGERY RETRACTORS, SINGLE-USE EUDAMED
- GMDN Term
- Intraocular retractor, 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
Set of 5 Iris Retractors 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 | 8052276FT0002ID8CV | 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 463ac710-3001-431f-b3b4-e7998e4b34f0 61 fields · synced Jun 20, 2026
- FDA UDI 1da531c5-6e84-4fce-b3f4-a981e57fadcd 36 fields · synced May 30, 2026