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Retinal Scraper 25G Full Handle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AK-0515/SModel Retinal Scraper /Scraper Retinico
by Aktive Srl
Identity
- Trade Name
- Retinal Scraper 25G Full Handle EUDAMEDFDA UDI
- Generic Name
- Epiretinal/inner limiting membrane scraper, single-use FDA UDI
- Device Name
- Retinal Scraper /Scraper Retinico EUDAMEDRetinal Scraper 25G Full Handle FDA UDI
- Model / Reference
- Retinal Scraper /Scraper Retinico EUDAMEDAK-0515/S EUDAMEDFDA UDI
- Description
- Retinal Scraper 25G Full Handle FDA UDI
Identifiers
- Catalog Number
- AK-0515/S FDA UDI
- Primary DI / UDI-DI
- 08052276027207 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0002ID4CM EUDAMED
- Unit of Use DI
- 08056477559543 EUDAMED
- FDA Product Code
- HND FDA UDI
- EMDN Code
- Q021109 OPHTHALMIC SURGERY SPATULAS, SINGLE-USE EUDAMED
- GMDN Term
- Epiretinal/inner limiting membrane scraper, 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
Retinal Scraper 25G Full Handle 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 | 8052276FT0002ID4CM | 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 4b6f5637-ce0d-44fa-9491-db6a9d191aa1 61 fields · synced Jul 15, 2026
- FDA UDI b3f88c39-a6ec-452b-9119-e9716cc4a629 36 fields · synced May 30, 2026