Identity
- Trade Name
- Disposable Reflective Marker Spheres EUDAMED
- Device Name
- 41773 Disposable Reflective Marker Spheres; 3 spheres per tray; 30 trays per box. Total 90 spheres per box EUDAMED
- Model / Reference
- 41773 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-41773GX EUDAMED
- Basic UDI-DI
- B-41773GX EUDAMED
- EMDN Code
- Z12130485 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Reflective Marker Spheres by Northern Digital Inc — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-41773GX | Class I | Active |
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Manufacturer
- Manufacturer
- Northern Digital Inc.
- EUDAMED SRN
- CA-MF-000023503
- Authorised Representative
- NDI Europe GmbH DE-AR-000019156
Sources (1)
- EUDAMED 0b956d0f-cda2-4592-ac81-e3277ea147e8 61 fields · synced May 22, 2026