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Organization name
UDI-DI code
Reference / catalog number

PC100012 — Class IIa MDR by terraplasma medical GmbH

MD Atlas
terraplasma medical GmbH

EUDAMED last updated this device on May 19, 2026

PC100012

426064454PCR6

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: terraplasma medical GmbH
UDI-DI code: 04260644540669
Reference / catalog number: PC100012

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Manufacturer information

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

Critical warnings

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

CW014
EUDAMED did not publish a description for this code.
CW259
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Apr 7, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260644540669
Basic UDI-DI: 426064454PCR6
Reference / catalog number: PC100012
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.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

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