Identity
- Device Name
- EM Spine Reference Frame Tracker EUDAMED
- Model / Reference
- 9736510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00763000989910 EUDAMED
- Basic UDI-DI
- 0763000B00033828E EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Category: Neurological stereotactic surgery system
EM Spine Reference Frame Tracker by Medtronic Navigation, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0763000B00033828E | Class I | Active |
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Manufacturer
- Manufacturer
- Medtronic Navigation Inc.
- EUDAMED SRN
- US-MF-000023263
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (1)
- EUDAMED a76207d8-e999-4c4b-86f7-334a6c06e57b 61 fields · synced Jul 18, 2026