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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

Z100.104 — Class I MDR by COLDPLASMATECH GmbH

MD Atlas
COLDPLASMATECH GmbH

EUDAMED last updated this device on Mar 9, 2026

Z100.104

PP10307CPT.BUDI.K000188

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: COLDPLASMATECH GmbH
UDI-DI code: 1310307Z100.104065
Reference / catalog number: Z100.104

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Manufacturer information

Organization name: COLDPLASMATECH GmbH
SRN: DE-MF-000010878
Manufacturer status: Active

Critical warnings

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

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

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2026	Still on market
Austria	Jan 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 1310307Z100.104065
Basic UDI-DI: PP10307CPT.BUDI.K000188
Reference / catalog number: Z100.104
Issuing entity: IFA

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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120499GENERAL MEDICINE INSTRUMENTS - 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

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Related devices

A100.T43PP10307CPT.BUDI.P000181On the market E100.113PP10307CPT.BUDI.C000141On the market