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SmartFrame XG Exchangeable Device Guides – Europe
EUDAMEDClass I (EU MDR)
Ref NGS-XG-01-E
Identity
- Trade Name
- SmartFrame XG Exchangeable Device Guides – Europe EUDAMED
- Device Name
- SmartFrame XG Exchangeable Device Guides – Europe EUDAMED
- Model / Reference
- NGS-XG-01-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850376007796 EUDAMED
- Basic UDI-DI
- 0850376007798V EUDAMED
- EMDN Code
- Z12100685 STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
SmartFrame XG Exchangeable Device Guides – Europe by Clearpoint Neuro, 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 | 0850376007798V | Class I | Active |
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Manufacturer
- Manufacturer
- ClearPoint Neuro, Inc.
- EUDAMED SRN
- US-MF-000010239
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 811a7178-0fcd-48fb-b1ef-e8ff196c0fdb 61 fields · synced Jun 19, 2026