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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

P000055 — Class I MDR by M Dialysis AB

MD Atlas
M Dialysis AB

EUDAMED last updated this device on Aug 26, 2025

P000055

7332699_330_011_WR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: M Dialysis AB
UDI-DI code: 07332699000416
Reference / catalog number: P000055

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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 P0001547332699_330_007_X6On the market 80501517332699_330_005_WYOn the market P0000567332699_330_010_WNOn the market 80101917332699_330_004_WVOn 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

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	May 20, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07332699000416
Basic UDI-DI: 7332699_330_011_WR
Reference / catalog number: P000055
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.mdialysis.com/products/user-manuals/
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)07332699000416

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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.

A010199NEEDLES FOR INFUSION AND COLLECTION - OTHER

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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