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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

70040 — Class I MDR by WERUNIA GmbH

MD Atlas
WERUNIA GmbH

EUDAMED last updated this device on Aug 14, 2025

70040

PP06830WKK.4868355

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: WERUNIA GmbH
UDI-DI code: 111989191211
Reference / catalog number: 70040

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Manufacturer information

Organization name: WERUNIA GmbH
SRN: DE-MF-000007299
Manufacturer status: Active

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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.

Critical warnings

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

CW999
Kalt-/Warmkompressen dürfen nicht bei Durchblutungsstörungen und Kälteüberempfindlichkeit, Raynaud-Syndrom angewendet werden. Anwendung bei Herz-, Kreislauferkrankung und Diabetes mellitus nur nach Rücksprache mit dem Arzt.
CW999
Überhitzung kann die Kompresse zerstören! Undichte oder entleerte Kompressen dürfen nicht mehr erwärmt und gebraucht werden!

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: not provided
UDI-DI code: 111989191211
Basic UDI-DI: PP06830WKK.4868355
Reference / catalog number: 70040
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)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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
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Software identification