Identity
- Trade Name
- Disposable Reflective Marker Sphere™ EUDAMED
- Device Name
- Disposable Reflective Marker Spheres EUDAMED
- Model / Reference
- 41813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00805832010032 EUDAMED
- Basic UDI-DI
- 805832DRMSM3 EUDAMED
- EMDN Code
- Z12011485,Z12100685,Z12130485 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Reflective Marker Sphere™ by Northern Digital Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805832DRMSM3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Northern Digital Inc.
- EUDAMED SRN
- CA-MF-000023503
- Authorised Representative
- NDI Europe GmbH DE-AR-000019156
Sources (1)
- EUDAMED aea2dabc-4110-40f1-a274-c50f3332e907 61 fields · synced Jun 18, 2026