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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

PlasmaDerm Dress — Class IIa MDR by CINOGY GmbH

MD Atlas
CINOGY GmbH

EUDAMED last updated this device on May 27, 2026

PlasmaDerm Dress

42606711700486

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CINOGY GmbH
UDI-DI code: 04260671170037
Reference / catalog number: K25400

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View device family (Basic UDI)

Manufacturer information

Organization name: CINOGY GmbH
SRN: DE-MF-000048574
Manufacturer status: Active

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Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW014
EUDAMED did not publish a description for this code.
CW133
EUDAMED did not publish a description for this code.
CW273
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: PlasmaDerm Dress
UDI-DI code: 04260671170037
Basic UDI-DI: 42606711700486
Reference / catalog number: K25400
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: 1
Additional product description: —
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)04260671170037

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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.

Z12019003WOUND TREATMENT EQUIPMENT

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.

CR-03-1211-881-25Issued
Quality management systemNotified body: 0537Expiry: Aug 14, 2030