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Swiss Bi-Manual I/A System curved / 23G Aeroplane

by Medicel AG 2 variants

Ref SBS320AModel SMS390S

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number076300552IA03YX Basic UDI-DI 07630055242853UDI-DIDate16 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07630055242853 UDI-DI Date6 Dec 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Swiss Bi-Manual I/A System curved / 23G Aeroplane EUDAMED
Swiss Bi-Manual I/A GUDID
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device Name
Swiss Coaxial I/A System Soft Tip angled 45° / 21G
Model / Ref / Catalog
SMS390S, SBS320A
Primary DI / UDI-DI
07630055242853
Basic UDI-DI
076300552IA03YX
Direct Marketing DI
07630055242853
FDA Product Code
HMX
EMDN Code
Q021101 Occular irrigation and aspiration cannulas, single-use
GMDN Term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
886.4350
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000016652
Authorised representative
Rudolf Riester GmbH DE-AR-000015844

Related devices

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Other devices from Medicel AG

See all devices from Medicel AG →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No