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Swiss Bi-Manual I/A System curved / 21G Aeroplane
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SBS310AModel SMS390S
by Medicel AG
Identity
- Trade Name
- Swiss Bi-Manual I/A System curved / 21G Aeroplane EUDAMEDSwiss Bi-Manual I/A FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Swiss Coaxial I/A System Soft Tip angled 45° / 21G EUDAMEDThe Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery. FDA UDI
- Model / Reference
- SMS390S EUDAMEDSBS310A EUDAMEDFDA UDI
- Description
- The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery. FDA UDI
Identifiers
- Catalog Number
- SBS310A FDA UDI
- Primary DI / UDI-DI
- 07630055242846 EUDAMEDFDA UDI
- Basic UDI-DI
- 076300552IA03YX EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Swiss Bi-Manual I/A System curved / 21G Aeroplane by Medicel AG — 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 | 076300552IA03YX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medicel AG
- EUDAMED SRN
- CH-MF-000016652
- Authorised Representative
- Rudolf Riester GmbH DE-AR-000015844
Sources (2)
- EUDAMED 80335fdf-82da-42a5-8a15-aed0821f5271 61 fields · synced Oct 7, 2026
- FDA UDI ea8942a2-e3b4-4081-a56b-0925035bb57d 35 fields · synced May 30, 2026