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Rossmax

by Rossmax Innotek Corp. 2 variants

Ref SA310, SB200, SB100, SA300, SD100, SB210

Active European Union

CE MDD

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/MDD NumberB-04712826091068 Basic UDI-DI Date9 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Handheld Pulse Oximeter
Fingertip Pulse Oximeter
Model / Reference
SA310, SB200, SB100, SA300, SD100, SB210
Primary DI / UDI-DI
04712826091068, 04712826092027, 04712826092010, 04712826091075, 04712826092058, 04712826092034, 04712826095066
Basic UDI-DI
B-04712826091068, B-04712826092027, B-04712826092010, B-04712826091075, B-04712826092058, B-04712826092034, B-04712826095066
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIb
EU market of registration
Germany
Greece
Belgium
Slovenia
Croatia

Manufacturer details

EUDAMED SRN
TW-MF-000013317
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Rossmax Innotek Corp.

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No