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

101.861-12u — IVDD — General IVDD by CareDx AB

MD Atlas
CareDx AB

EUDAMED last updated this device on Apr 17, 2026

101.861-12u

B-07340035506409

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: CareDx AB
UDI-DI code: 07340035506409
Reference / catalog number: 101.861-12u

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: CareDx AB
SRN: SE-MF-000040995
Manufacturer status: Active

Related devices

101.122-06uB-07340035500568On the market 101.851-12uB-07340035505020On the market 101.702-24uB-07340035507062On the market 104.101-12uB-07340035508069On the market 303.701-01B-07340035519003On the market

Certificates

Certificate health across this manufacturer's portfolio.

HX 7091956-1Issued
Quality management systemNotified body: 0197Expiry: Sep 23, 2030

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 Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07340035506409
Basic UDI-DI: B-07340035506409
Reference / catalog number: 101.861-12u
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SSP HLA-Cw*04:09N, 12 test kit
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

Encoded

(01)07340035506409

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

W01030403HLA ANTIGEN TYPING

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Become a partner of MD Atlas