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NeXus | 10 MK3 Medical

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 70-0008-1001Model NeXus 10 MK3

by Mind Media Europe B.V.

Identity

Trade Name
NeXus | 10 MK3 Medical EUDAMED
NeXus 10 MK3 FDA UDI
Generic Name
Multiple physiological signal amplifier FDA UDI
Device Name
NeXus | 10 MK3 EUDAMED
The NeXus | 10 MK3 is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/access professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MK3 is not intended for use in diagnosis, nor in critical and/or life supporting applications. The NeXus 10 MK3 is intended for use on humans. The NeXus 10 MK3 is intended to be used with approved NeXus 10 accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus 10 and may require interpretation by user or application software. FDA UDI
Model / Reference
NeXus 10 MK3 EUDAMED
70-0008-1001 EUDAMED
1.0 FDA UDI
Description
The NeXus | 10 MK3 is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/access professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MK3 is not intended for use in diagnosis, nor in critical and/or life supporting applications. The NeXus 10 MK3 is intended for use on humans. The NeXus 10 MK3 is intended to be used with approved NeXus 10 accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus 10 and may require interpretation by user or application software. FDA UDI

Identifiers

Primary DI / UDI-DI
08719481550110 EUDAMEDFDA UDI
Basic UDI-DI
871948155010NX1038A EUDAMED
Direct Marketing DI
08719481550110 EUDAMED
FDA Product Code
HCC FDA UDI
EMDN Code
Z12062499 BIOFEEDBACK INSTRUMENTS - OTHER EUDAMED
GMDN Term
Multiple physiological signal amplifier FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

NeXus | 10 MK3 Medical by Mind Media Europe B.V. — 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

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Manufacturer

Manufacturer
Mind Media Europe B.V.
EUDAMED SRN
NL-MF-000001576

Sources (2)

  • EUDAMED 7eef6305-40f9-4a3a-aaf4-3feaca023b17 61 fields · synced Jun 19, 2026
  • FDA UDI c9ad2150-7166-433b-9b52-df630452d48f 33 fields · synced May 30, 2026