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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 RapiDx — IVDD — General IVDD by RAM THz Solutions GmbH

MD Atlas
RAM THz Solutions GmbH

EUDAMED last updated this device on Aug 8, 2022

ThEA RapiDx

B-DEMF0000239784000RD7R

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-DEMF0000239784000RD7R
Reference / catalog number: 4000RapiDx

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Manufacturer information

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

Critical warnings

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

CW010
Read the user manual before any operation of the system
CW011
Instrument classified as class 1 laser

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 RapiDx
UDI-DI code: D-DEMF0000239784000RD7R
Basic UDI-DI: B-DEMF0000239784000RD7R
Reference / catalog number: 4000RapiDx
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: A bench-top terahertz spectroscope designed to measure interaction ofsamples and sensor with electromagnetic fields in the range of 0.1 to 5THz. A computer with touchscreen is embedded within the self-containedunit for the user to interface with the instrument. Users can control theThEA RapiDx and perform the measurements via the use of the pre-installed ThEA Control Software. The Software is used to control themeasurements. It enables the user to enter sample information and startthe reference and sample measurements.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0299IVD INSTRUMENTS - 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

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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.