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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

8010514 — Class IIa MDR by M Dialysis AB

MD Atlas
M Dialysis AB

EUDAMED last updated this device on Aug 17, 2025

8010514

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: 07332699000492
Reference / catalog number: 8010514

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View device family (Basic UDI)

Manufacturer information

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

Related devices

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
Do not use the catheter if the mass of the liver tissue is very small.
CW999
Inserting the catheter into the tissue may cause bleeding from damaged vessels.
CW999
The catheter shall not be left in the liver after closing of the abdomen, as the liquid cross must be placed outside the body

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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: 07332699000492
Basic UDI-DI: 7332699_320_005_WF
Reference / catalog number: 8010514
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: 20000 MU131
30 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07332699000492

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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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