Identity
- Trade Name
- NaoTrac EUDAMED
- Device Name
- Surgical Navigation Robot EUDAMEDStereotaxic Guiding Surgical Devices EUDAMED
- Model / Reference
- NaoTrac EUDAMEDFPNT0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878690010 EUDAMED04719878691000 EUDAMED
- Basic UDI-DI
- B-04719878690010 EUDAMEDB-04719878691000 EUDAMED
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMEDZ12100601 STEREOTACTIC NEUROSURGERY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
NaoTrac by Brain Navi Biotechnology Co., Ltd. — Class IIb — 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-04719878690010 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Brain Navi Biotechnology Co., Ltd.
- EUDAMED SRN
- TW-MF-000016990
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 493c20b7-c04d-47a6-a8d6-9900e4631648 61 fields · synced Jul 11, 2026
- EUDAMED 4c8c46e2-ef48-40bc-9d03-14f903b83b1f 61 fields · synced May 17, 2026