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SmartFrame XG – Europe
EUDAMEDClass IIa (EU MDR)
Ref NGS-SF-02-11-EModel NGS-SF-02-11-5-E
Identity
- Trade Name
- SmartFrame XG – Europe EUDAMED
- Device Name
- SmartFrame XG, 5 Fr – Europe EUDAMED
- Model / Reference
- NGS-SF-02-11-5-E EUDAMEDNGS-SF-02-11-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850376007680 EUDAMED
- Basic UDI-DI
- 0850376007688Q EUDAMED
- EMDN Code
- Z12100685 STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa 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 – Europe by Clearpoint Neuro, Inc. — Class IIa — 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 | 0850376007688Q | Class IIa | 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 c1f0b02f-f699-41eb-a072-ec46be4926be 61 fields · synced Jul 9, 2026