← Back to catalogue
Eye Shield
EUDAMEDFDA UDIClass I (EU MDR)
Ref AK-2000Model Eye Shield /Coppetta post chirurgica
by Aktive Srl
Identity
- Trade Name
- Eye Shield EUDAMEDFDA UDI
- Generic Name
- Postsurgical eye shield, vented FDA UDI
- Device Name
- Eye Shield /Coppetta Oculare EUDAMEDEye Shield FDA UDI
- Model / Reference
- Eye Shield /Coppetta post chirurgica EUDAMEDAK-2000 EUDAMEDFDA UDI
- Description
- Eye Shield FDA UDI
Identifiers
- Catalog Number
- AK-2000 FDA UDI
- Primary DI / UDI-DI
- 08052276029638 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0003ID4CU EUDAMED
- Unit of Use DI
- 08058340229232 EUDAMED
- FDA Product Code
- HOY FDA UDI
- EMDN Code
- Q029001 RIGID MONOCULAR MASKS EUDAMED
- GMDN Term
- Postsurgical eye shield, vented FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4750 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
Eye Shield 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 | 8052276FT0003ID4CU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aktive Srl
- EUDAMED SRN
- IT-MF-000007813
Sources (2)
- EUDAMED e36ed6e4-dfb2-4edb-9761-11d6e31d75f7 61 fields · synced Jul 29, 2026
- FDA UDI 7962d250-85bc-413d-938d-999654229c50 35 fields · synced May 30, 2026