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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

8010651 — Class IIa MDR by M Dialysis AB

MD Atlas
M Dialysis AB

EUDAMED last updated this device on Aug 15, 2025

8010651

7332699_320_003_W9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: M Dialysis AB
UDI-DI code: 07332699000522
Reference / catalog number: 8010651

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View device family (Basic UDI)

Manufacturer information

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

Critical warnings

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

CW999
Patients with known hypersensitivity to Dextran.
CW999
Inserting the catheter into the tissue may cause bleeding from damaged vessels.

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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: 07332699000522
Basic UDI-DI: 7332699_320_003_W9
Reference / catalog number: 8010651
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: 30 MU50
100000 MU131

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07332699000522

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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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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