Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

008 — 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

008

++G286HSeqDQBMK

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: +G2860080_
Reference / catalog number: 008

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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: +G2860080_
Basic UDI-DI: ++G286HSeqDQBMK
Reference / catalog number: 008
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-DQB ist ein In vitro Diagnostikum, das für die hochauflösende Typisierung der HLA-Merkmale DQB 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

+G2860080_

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

Become a partner of MD Atlas

Related devices

001++G286HSeqABCKROn the market 015++G286HSeqDPBMGOn the market 002++G286HSeqDRHHOn the market 021++G286LongRangeNGS7KOn the market 014++G286HSeqNGSP9On 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.