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Organization name
UDI-DI code
Reference / catalog number

plasma derma care — Class I MDR by terraplasma medical GmbH

MD Atlas
terraplasma medical GmbH

EUDAMED last updated this device on Jul 25, 2024

plasma derma care

426064454PDCFZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: terraplasma medical GmbH
UDI-DI code: 04260644540096
Reference / catalog number: PC100004

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Manufacturer information

Organization name: terraplasma medical GmbH
SRN: DE-MF-000011250
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: plasma derma care
UDI-DI code: 04260644540096
Basic UDI-DI: 426064454PDCFZ
Reference / catalog number: PC100004
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: Device is to be used together with a spacer from the plasma derma care family
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

HZ 1380540-1Issued
Quality management systemNotified body: 0197Expiry: Nov 12, 2029