Identity
- Trade Name
- CereLink™ EUDAMEDFDA UDI
- Generic Name
- Intracranial pressure monitor FDA UDI
- Device Name
- Intracranial Pressure Sensor Ventricular Catheter EUDAMEDCereLink™ ICP Sensor Ventricular Catheter Kit with ICP Sensor FDA UDI
- Model / Reference
- 826854 EUDAMEDFDA UDI
- Description
- CereLink™ ICP Sensor Ventricular Catheter Kit with ICP Sensor FDA UDI
Identifiers
- Catalog Number
- 82-6854 FDA UDI
- Primary DI / UDI-DI
- 10381780520702 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10381780520702 EUDAMED
- FDA Product Code
- GWM FDA UDI
- EMDN Code
- Z12039001 INTRACRANIAL PRESSURE MEASURING SYSTEMS EUDAMED
- GMDN Term
- Intracranial pressure monitor FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Intracranial pressure monitor
CereLink™ by Integra LifeSciences Production Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (2)
- FDA UDI a84b976e-7f6a-4ffb-8601-3b6eb2f8b5d3 36 fields · synced Oct 7, 2026
- EUDAMED c35b0817-f20d-495b-839d-f7c58b423a62 61 fields · synced Oct 7, 2026