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STERiLANCE

by Sterilance Medical (Suzhou) Inc. 18 variants

Ref "30mm x60mm 70% lsopropyl Alcohol 06-023060"Model 75% Ethyl Alcohol, 70% Isopropyl Alcohol

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6945630106BK Basic UDI-DI Date24 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Alcohol Swabs
Model / reference
75% Ethyl Alcohol, 70% Isopropyl Alcohol, "30mm x60mm 70% lsopropyl Alcohol 06-023060"
Primary DI / UDI-DI
16945630143967, 16945630143950, 16945630143981
Basic UDI-DI
6945630106BK
Unit of use DI
06945630143960, 06945630143984
EMDN code
D0702 Isopropyl alcohol for the disinfection of medical devices
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000002860
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Sterilance Medical (Suzhou) Inc.

See all devices from Sterilance Medical (Suzhou) Inc. →

Properties

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No