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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Thermodiag Bt — Class I MDR by F2D MEDICAL

MD Atlas
F2D MEDICAL

EUDAMED last updated this device on Aug 28, 2025

Thermodiag Bt

376039807HC0015A

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: F2D MEDICAL
UDI-DI code: 03760398070050
Reference / catalog number: TH01-10Bt01

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Manufacturer information

Organization name: F2D MEDICAL
SRN: FR-MF-000035850
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: Thermodiag Bt
UDI-DI code: 03760398070050
Basic UDI-DI: 376039807HC0015A
Reference / catalog number: TH01-10Bt01
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Thermodiag Band tape is a hygienic, disposable, non-woven, and non-compressive cover designed to be replaced every 24 hours. It is a class I medical device used with the Thermodiag Armband to secure and position the armband’s sensors on the patient’s arm for continuous monitoring of core body temperature.
Additional information URL: https://f2d-medical.com/
Clinical sizes: 55cm X 5cm - 22in X 2in

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.