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41813 Disposable Reflective Marker Spheres +2 more models
EUDAMEDClass I (EU MDR)
Ref 41813
Identity
- Device Name
- 41813 Disposable Reflective Marker Spheres; 2 spheres per tray; 30 trays per box. Total 60 spheres per box EUDAMED
- Model / Reference
- 41813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-41813GJ EUDAMED
- Basic UDI-DI
- B-41813GJ EUDAMED
- EMDN Code
- Z12130485 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- Models / Variants
- 2 spheres per tray 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
41813 Disposable Reflective Marker Spheres +2 more models by Northern Digital Inc — Class I — MDD — listed in EUDAMED — 3 models — 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-41813GJ | 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 0b7163f6-86a1-4ad0-aa32-baac57913216 61 fields · synced Jun 18, 2026