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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

101.103-48u — IVDD — Annex II List B IVDD by CareDx AB

MD Atlas
CareDx AB

EUDAMED last updated this device on Apr 13, 2026

101.103-48u

B-07340035500759

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: CareDx AB
UDI-DI code: 07340035500759
Reference / catalog number: 101.103-48u

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View device family (Basic UDI)

Manufacturer information

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

Related devices

101.117-03uB-07340035500360On the market 101.116-03uB-07340035500322On the market 101.116-24uB-07340035500308On the market 101.115-03uB-07340035500285On the market 101.103-12uB-07340035500773On 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.

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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: 07340035500759
Basic UDI-DI: B-07340035500759
Reference / catalog number: 101.103-48u
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
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 DR low Screening, 48 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)07340035500759

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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

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