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ClearPoint Inflexion Aera-Skyra HFF
EUDAMEDFDA UDIClass I (EU MDR)
Ref CP-INHFF-122-01
Identity
- Trade Name
- ClearPoint Inflexion Aera-Skyra HFF EUDAMEDClearPoint FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- ClearPoint Inflexion EUDAMEDClearPoint Inflexion Aera-Skyra HFF FDA UDI
- Model / Reference
- CP-INHFF-122-01 EUDAMEDFDA UDI
- Description
- ClearPoint Inflexion Aera-Skyra HFF FDA UDI
Identifiers
- Catalog Number
- CP-INHFF-122-01 FDA UDI
- Primary DI / UDI-DI
- 00850376007499 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850376007488J EUDAMED
- Direct Marketing DI
- 00850376007499 EUDAMED
- 510(k) Number
- K191701 FDA UDI
- FDA Product Code
- HBL FDA UDI
- EMDN Code
- Z12100680 STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4460 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
ClearPoint Inflexion Aera-Skyra HFF by Clearpoint Neuro, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850376007488J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClearPoint Neuro, Inc.
- EUDAMED SRN
- US-MF-000010239
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 42737a70-15b3-485a-9116-12288c2fc6e8 61 fields · synced Jun 18, 2026
- FDA UDI 7cf52857-a042-4b09-ae3f-6a0347f01465 36 fields · synced May 30, 2026