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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

MD008 — Class IIa MDR by TCC GmbH

MD Atlas
TCC GmbH

EUDAMED last updated this device on Mar 2, 2026

MD008

426243535MD008Y2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TCC GmbH
UDI-DI code: 04262435350051
Reference / catalog number: MD008

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Manufacturer information

Organization name: TCC GmbH
SRN: DE-MF-000036584
Manufacturer status: Active

Critical warnings

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

CW010
It is specifically designed for adult patients (olter than 18 years of age). The backend service is not intended for use in patients receiving medication that affects the relevant vital signs. Patients with a previously diagnosed sepsis are also excluded.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 2, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262435350051
Basic UDI-DI: 426243535MD008Y2
Reference / catalog number: MD008
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Sepsis Prediction Service is a backend service of an algorithm of a clinical flag intended to predict an adult‘s probability of developing a Sepsis. The backend service can be called via an open API from any calling platform, by transmitting all necessary input data. It returns a risk label and color code to the calling platform. There is no direct user-interaction with this service.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

MD003426243535MD003XQOn the market MD002426243535MD002XNOn 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.