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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

MD003 — Class IIa MDR by TCC GmbH

MD Atlas
TCC GmbH

EUDAMED last updated this device on Dec 15, 2025

MD003

426243535MD003XQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TCC GmbH
UDI-DI code: 04262435350020
Reference / catalog number: MD003

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Manufacturer information

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

Related devices

MD008426243535MD008Y2On 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.

Critical warnings

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

CW010
Contraindication: It is specifically designed for adult patients (older than 18 years of age). Pregnant women are not included. Special caution is advised when interpreting the score in patients with chronic obstructive pulmonary disease (COPD).

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Dec 12, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262435350020
Basic UDI-DI: 426243535MD003XQ
Reference / catalog number: MD003
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: Early Deterioration Service is a backend service of an algorithm of a clinical score intended to be used as a clinical decision support tool to indicate an adult‘s physiological condition and risk of deterioration. The backend service can be called via an open API from any calling platform, by transmitting all necessary input data. It returns a clinical score to the calling plattform. 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
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Software identification