GSR-TMP Sensor

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 80-0101-0003

by Mind Media Europe B.V.

Identity

Trade Name: GSR-TMP Combination Sensor (NC-C-GT) FDA UDI
Generic Name: General-purpose patient temperature probe, reusable FDA UDI
Device Name: GSR-TMP Sensor EUDAMED
NC-C-GT: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. FDA UDI
Model / Reference: 80-0101-0003 EUDAMED
1.0 FDA UDI
Description: NC-C-GT: The GSR sensor provides a measure of skin resistance or skin conductance when connected to a NeXus signal acquisition device, which is influenced by the autonomic activation of sweat glands in the skin. The sensor output is not intended to be used for vital monitoring purposes. The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment. FDA UDI

Identifiers

Primary DI / UDI-DI: 08719481550097 EUDAMEDFDA UDI
Basic UDI-DI: 0871948155GSRD2 EUDAMED
FDA Product Code: HCC FDA UDI
EMDN Code: Z12062480 BIOFEEDBACK INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: General-purpose patient temperature probe, reusable 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

GSR-TMP Sensor 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	0871948155GSRD2	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

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

Sources (2)

EUDAMED c7d7f253-2a23-4f88-b6a6-40e83f3e4cb7 61 fields · synced Jun 19, 2026
FDA UDI b3ffc769-4722-4276-ba55-2dfa43a56b67 33 fields · synced May 30, 2026