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Passive Spheres™

by Northern Digital Inc. 4 variants

Part of a family of 15 devices: see the family page

Ref 8801074

Passive Spheres™ (8801074) is a Class I device made by Northern Digital Inc, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 805832PassiveJ5), active as of 23 Oct 2026.

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805832PassiveJ5 Basic UDI-DI 00805832070067UDI-DIDate30 Jun 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Passive Reflective Markers
Model / reference
8801074
Primary DI / UDI-DI
00805832070067
Basic UDI-DI
805832PassiveJ5
EMDN code
Z12011485, Z12100685, Z12130485
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CA-MF-000023503
Authorised representative
NDI Europe GmbH DE-AR-000019156

Similar devices in this category

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Other devices from Northern Digital Inc

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Properties

  • Supplied sterile
Other properties (13, all answered No)