Passive Spheres™
by Northern Digital Inc. 4 variants
Part of a family of 15 devices: see the family page
Ref 8801071
Passive Spheres™ (8801071) is a Class I device made by Northern Digital Inc, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 805832PassiveJ5), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805832PassiveJ5 00805832070050 | Date30 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 805832PassiveJ5
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Passive Reflective Markers
- Model / reference
- 8801071
- Primary DI / UDI-DI
- 00805832070050
- 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
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