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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 45 01 — Class I MDR by Tec Com Medizintechnik…

MD Atlas
Tec Com Medizintechnik GmbH

EUDAMED last updated this device on Jan 21, 2025

928 45 01

4260647540147X2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tec Com Medizintechnik GmbH
UDI-DI code: 04260647540147
Reference / catalog number: 928 45 01

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Manufacturer information

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

Critical warnings

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

CW999
Do not look directly into the light source or direct it at the patient’s head. Note: this can lead to impaired vision.

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: 04260647540147
Basic UDI-DI: 4260647540147X2
Reference / catalog number: 928 45 01
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 Venoray is a portable LED light source for locating blood vessels in the extremities of premature babies, infants and young children.
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

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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.