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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

8050191 — Class IIa MDR by M Dialysis AB

MD Atlas
M Dialysis AB

EUDAMED last updated this device on Aug 19, 2025

8050191

7332699_320_005_WF

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: M Dialysis AB
UDI-DI code: 07332699001444
Reference / catalog number: 8050191

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View device family (Basic UDI)

Manufacturer information

Organization name: M Dialysis AB
SRN: SE-MF-000017466
Manufacturer status: Active

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P0000347332699_330_005_WYOn the market P0000557332699_330_011_WROn the market P0001547332699_330_007_X6On the market 80501517332699_330_005_WYOn the market P0000567332699_330_010_WNOn the market

Certificates

Certificate health across this manufacturer's portfolio.

28620170242Issued
Quality management systemNotified body: 2862Expiry: Dec 18, 2028
28620178542Issued
Quality management systemNotified body: 2862Expiry: Dec 18, 2028
28620178540Issued
Quality management systemNotified body: 2862Expiry: Dec 18, 2028

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW999
Inserting the catheter may cause bleeding from damaged vessels.
CW999
Usage in Hepatic tissue: Do not use the catheter if the mass of the liver tissue is very small
CW999
For 61 High Cut Off Microdialysis Catheter: Patients with known hypersensitivity to Dextran.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	May 20, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07332699001444
Basic UDI-DI: 7332699_320_005_WF
Reference / catalog number: 8050191
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 4
Additional product description: —
Additional information URL: https://www.mdialysis.com/products/user-manuals/
Clinical sizes: 100000 MU131
30 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07332699001444

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

F05DEVICES FOR MICRODIALYSIS OF SPECIFIC ORGANS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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