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Stab Knife 15° with protection
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref I-15PModel Knife/Bisturi
by Aktive Srl
Identity
- Trade Name
- Stab Knife 15° with protection EUDAMEDFDA UDI
- Generic Name
- Ophthalmic knife, single-use FDA UDI
- Device Name
- Knife/Bisturi EUDAMEDStab Knife 15° with protection FDA UDI
- Model / Reference
- Knife/Bisturi EUDAMEDI-15P EUDAMEDFDA UDI
- Description
- Stab Knife 15° with protection FDA UDI
Identifiers
- Catalog Number
- I-15P FDA UDI
- Primary DI / UDI-DI
- 08052276033840 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0002ID2CH EUDAMED
- Unit of Use DI
- 08058340226125 EUDAMED
- FDA Product Code
- HNN FDA UDI
- EMDN Code
- Q021109 OPHTHALMIC SURGERY SPATULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic knife, 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
Dimensions & Sizes
- Size
- Angle — 15 degree FDA UDI
Stab Knife 15° with protection 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 | 8052276FT0002ID2CH | 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 7ff123ff-6028-4207-b62a-759e04405644 61 fields · synced Jul 8, 2026
- FDA UDI 948304a5-12d9-458e-914c-d8b1d44fa2a7 36 fields · synced May 30, 2026