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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

928 21 10 — Class I MDR by Tec Com Medizintechnik…

MD Atlas
Tec Com Medizintechnik GmbH

EUDAMED last updated this device on Jan 21, 2025

928 21 10

4260647540239X8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tec Com Medizintechnik GmbH
UDI-DI code: 04260647540239
Reference / catalog number: 928 21 10

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Manufacturer information

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

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: 04260647540239
Basic UDI-DI: 4260647540239X8
Reference / catalog number: 928 21 10
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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

Related devices

64268014260647540031WEOn the market 64274104260647540017WLOn the market 928 32 104260647540123WLOn the market 928 20 104260647540123WLOn the market 928 31 104260647540239X8On 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.