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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

SET ON/OFF DIALYSIS — Class I MDR by D.R.M. S.R.L.

MD Atlas
D.R.M. S.R.L.

EUDAMED last updated this device on Feb 9, 2026

SET ON/OFF DIALYSIS

805959152KITD1SMT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: D.R.M. S.R.L.
UDI-DI code: 08059591521205
Reference / catalog number: DR 2202/MB

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View device family (Basic UDI)

Manufacturer information

Organization name: D.R.M. S.R.L.
SRN: IT-MF-000027115
Manufacturer status: Active

Related devices

DR/ESP-2805959152APCPFOn the market DR/ESP-1805959152APCPFOn the market BANDAGE COHÉSIF POUR FISTULE805959152PREMN4On the market IB0786805959152PREMN4On the market DR 10-1A805959152PREMN4On the market

Certificates

Certificate health across this manufacturer's portfolio.

55998Reissued
Quality assuranceNotified body: 0546Expiry: Jan 24, 2028
55998Issued
Quality assuranceNotified body: 0546Expiry: Jan 24, 2028

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Slovenia; available across 1 country total.

Placed on the market in Slovenia; per-country availability dates not published.

Device identification

Trade name: SET ON/OFF DIALYSIS
UDI-DI code: 08059591521205
Basic UDI-DI: 805959152KITD1SMT
Reference / catalog number: DR 2202/MB
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: Dialysis dressing on/off set
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)08059591521205

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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.

T0203DRESSING AND ASSISTANCE KITS

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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