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Set Bi-Manual I/A Handpieces Sanded 21G
EUDAMEDClass IIa (EU MDR)
Ref AK-0439/SModel Bimanual Cannulae / Cannule Bimanuali
by Aktive Srl
Identity
- Trade Name
- Set Bi-Manual I/A Handpieces Sanded 21G EUDAMED
- Device Name
- Bimanual Cannulae / Cannule Bimanuali EUDAMED
- Model / Reference
- Bimanual Cannulae / Cannule Bimanuali EUDAMEDAK-0439/S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052276034427 EUDAMED
- Basic UDI-DI
- 8052276FT0001ID7CL EUDAMED
- Unit of Use DI
- 08052276034410 EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Set Bi-Manual I/A Handpieces Sanded 21G by Aktive Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8052276FT0001ID7CL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aktive Srl
- EUDAMED SRN
- IT-MF-000007813
Sources (1)
- EUDAMED 11075103-0893-4e2a-abd8-0b81f0995c9b 61 fields · synced Jul 8, 2026