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Mjw

by MJW International

Ref MJW-001, mjw-001

Active European Union

CE MDR 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/MDR NumberB-+G6330010R Basic UDI-DI +G6330010RUDI-DIDate30 Apr 2024RegisteredStatusActive
European UnionCE/MDD NumberB-+G6330010R Basic UDI-DI +G6330010RUDI-DIDate30 Apr 2024RegisteredStatusActive

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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Otoscope
Model / Reference
MJW-001
Primary DI / UDI-DI
+G6330010R
Basic UDI-DI
B-+G6330010R, ++G633Otoscope5X
Direct Marketing DI
+G6330010R
EMDN Code
Z12021007 Middle ear otoscopes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
PK-MF-000041059
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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