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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

TE1112 — IVDR Class A IVDR by TECOmedical AG

MD Atlas
TECOmedical AG

EUDAMED last updated this device on May 19, 2025

TE1112

0764014627TE1112QC

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: TECOmedical AG
UDI-DI code: 07640146270207
Reference / catalog number: TE1112

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Manufacturer information

Organization name: TECOmedical AG
SRN: CH-MF-000030341
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: 07640146270207
Basic UDI-DI: 0764014627TE1112QC
Reference / catalog number: TE1112
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Wash solution to be used for TECO® Intact proinsulin ELISA (TE1012)
Additional information URL: https://www.tecomedical.com/login
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01029003BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

TE1017-2B-07640146270047On the market TE1067B-07640146270078On the market TE1013B-07640146270023On the market TE1012B-07640146270016On the market TE1069B-07640146270108On 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.