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Basic Information
- Number
- FI23/00000060
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- December 28, 2023
- Expiry Date
- December 27, 2027
- Revision
- Issue 1
- Manufacturer
- Cerenion Ltd
Certificate Lifecycle
Conditions
English
Limited to be used in conjunction with a state-of-the-art neurological monitoring setup as supporting neurological state indication with linkage to measured and recorded EEG data. Active collection and reporting of post market clinical follow-up data for long-term safety evidence is required as a condition for maintaining certification.
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
Medical device software, Z12100392 Electroencephalography instruments.
Quality Procedure Scope
Basic UDI-DIs
This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.