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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

E100.113 — Class IIb MDR by COLDPLASMATECH GmbH

MD Atlas
COLDPLASMATECH GmbH

EUDAMED last updated this device on Mar 9, 2026

E100.113

PP10307CPT.BUDI.C000141

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: COLDPLASMATECH GmbH
UDI-DI code: 1310307E100.113069
Reference / catalog number: E100.113

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Manufacturer information

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

Critical warnings

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

CW259
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW016
EUDAMED did not publish a description for this code.
CW274
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: 1310307E100.113069
Basic UDI-DI: PP10307CPT.BUDI.C000141
Reference / catalog number: E100.113
Issuing entity: IFA

Classification

Risk category: Class IIb
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

Related devices

Z100.104PP10307CPT.BUDI.K000188On the market A100.T43PP10307CPT.BUDI.P000181On the market

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.