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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

015 — IVDR Class C IVDR by Institut für Klinische…

MD Atlas
Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH

EUDAMED last updated this device on Dec 21, 2023

015

++G286HSeqDPBMG

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
UDI-DI code: +G2860150-
Reference / catalog number: 015

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Manufacturer information

Organization name: Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH
SRN: DE-MF-000018980
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: +G2860150-
Basic UDI-DI: ++G286HSeqDPBMG
Reference / catalog number: 015
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 1
Additional product description: H-Seq-DPB ist ein In vitro Diagnostikum, das für die hochauflösende Typisierung der HLA-Merkmale DPB eingesetzt wird.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+G2860150-

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W01030403HLA ANTIGEN TYPING
W0106010401HLA-TYPING

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.