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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

ThEA Diagnostic Sensor Stick-F1 — IVDD — General IVDD

MD Atlas
RAM THz Solutions GmbH

EUDAMED last updated this device on Aug 8, 2022

ThEA Diagnostic Sensor Stick-F1

B-DEMF0000239784300F16J

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: RAM THz Solutions GmbH
UDI-DI code: D-DEMF0000239784300F16J
Reference / catalog number: 4300F1

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Manufacturer information

Organization name: RAM THz Solutions GmbH
SRN: DE-MF-000023978
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: ThEA Diagnostic Sensor Stick-F1
UDI-DI code: D-DEMF0000239784300F16J
Basic UDI-DI: B-DEMF0000239784300F16J
Reference / catalog number: 4300F1
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The ThEA DSS-F1 consists of a holder and a metamaterial sensor antenna enclosed in it, which has been specially optimized for the detection of theSARS-CoV-2 virus and its membrane proteins. When exposed to electromagnetic THz radiation, the antenna structures interact with the biological matter in contact, in this case the SARS CoV-2 virus. As a result, specific vibration modes in the 0.6 and 1.2 THz range are amplified and read out as a signal. The patient sample is directly applied to the sensor surface of the Sensor Stick and left to dry for at least 15 seconds. The Sensor Stick is then inserted into the ThEA RapiDx.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

ThEA RapiDxB-DEMF0000239784000RD7ROn the market ThEA SARS-CoV-2 pluginB-DEMF0000239784310SC92On the market

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.