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Femto I/A Handpieces 30°/19G
EUDAMEDClass IIa (EU MDR)
Ref SMS440Model SMS390S
by Medicel AG
Identity
- Trade Name
- Femto I/A Handpieces 30°/19G EUDAMED
- Device Name
- Swiss Coaxial I/A System Soft Tip angled 45° / 21G EUDAMED
- Model / Reference
- SMS390S EUDAMEDSMS440 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630055243270 EUDAMED
- Basic UDI-DI
- 076300552IA03YX EUDAMED
- Direct Marketing DI
- 07630055243270 EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Femto I/A Handpieces 30°/19G by Medicel AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Soft Tip Cannula 20g, 0.8mm tip — Psi/Eye-Ko, Inc. · Class IIa
- I/A HDP. 45 W SLEEVE 1.8 12/BX — Bausch & Lomb, Inc. · Class II
- Visitec® — Beaver-Visitec International, Inc. · Class I
- 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 | 076300552IA03YX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medicel AG
- EUDAMED SRN
- CH-MF-000016652
- Authorised Representative
- Rudolf Riester GmbH DE-AR-000015844
Sources (1)
- EUDAMED 9106ae51-54b9-4bcb-9d69-ca168d727c61 61 fields · synced Jun 19, 2026