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Monomanual I/A System reusable

by Bürki inno med AG 13 variants

Ref 1901-5022, SL 116, SL 119 a11, SL 110/0.3, SL 119 a13, SL 110, SL 118 c1, SL 118 c2, SL 115, SL 119 a22, SL 116 s1, SL 119 a21, SL 118 c4, SL 120 45°, SL 117, SL 119 a24, 1901-5021, SL 140, SL 119 a12

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764013745P02P04X4 Basic UDI-DI Date24 Apr 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
I/A System reusable
Model / Reference
1901-5022, SL 116, SL 119 a11, SL 110/0.3, SL 119 a13, SL 110, SL 118 c1, SL 118 c2, SL 115, SL 119 a22, SL 116 s1, SL 119 a21, SL 118 c4, SL 120 45°, SL 117, SL 119 a24, 1901-5021, SL 140, SL 119 a12
Primary DI / UDI-DI
07640137454036, 07640137450656, 07640137451905, 07640137451509, 07640137451929, 07640137450632, 07640137451837, 07640137451844, 07640137450649, 07640137451882, 07640137451790, 07640137451875, 07640137451868, 07640137450670, 07640137451103, 07640137451936, 07640137454029, 07640137450694, 07640137451912
Basic UDI-DI
764013745P02P04X4
Direct Marketing DI
07640137454036
07640137450656
07640137451905
07640137451509
07640137451929
07640137450632
07640137451837
07640137451844
07640137450649
07640137451882
07640137451790
07640137451875
07640137451868
07640137450670
07640137451103
07640137451936
07640137454029
07640137450694
07640137451912
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000017443
Authorised representative
Bürki inno med GmbH DE-AR-000008073

From the manufacturer

Manufacturer's product page: Monomanual I/A System reusable (SAFE-LOCK I/A Coaxial System)

Other devices from Bürki inno med AG

See all devices from Bürki inno med AG →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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