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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

6427410 — Class I MDR by Tec Com Medizintechnik…

MD Atlas
Tec Com Medizintechnik GmbH

EUDAMED last updated this device on Jul 2, 2024

6427410

4260647540017WL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tec Com Medizintechnik GmbH
UDI-DI code: 04260647540017
Reference / catalog number: 6427410

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Manufacturer information

Organization name: Tec Com Medizintechnik GmbH
SRN: DE-MF-000004978
Manufacturer status: Active

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
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: not provided
UDI-DI code: 04260647540017
Basic UDI-DI: 4260647540017WL
Reference / catalog number: 6427410
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 mattress is used for full body temperature control of patients, principally newborns and infants. It connects to the TECOtherm NEO via the hose set and temperature regulated liquid flows through the system. In order to improve the temperature control of the patient, the mattress can be wrapped around the body if necessary and closed with securing straps on the eyelets.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 42cm x 62cm

EMDN nomenclature code(s)

V0299NEONATOLOGY AND PAEDIATRIC DEVICES - 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

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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.