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EUDAMED last updated this device on Aug 14, 2025
PP06830WKK.4868355Kalt Warmkompresse 260g TD is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by WERUNIA GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
11198919121170040111989191211
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES2 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
DE-MF-000007299Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
PP06830EB.40331353On the marketErste-Hilfe-Box 36 tlg.PP06830WP.53012359On the marketFingerlinge und FingerverbandPP06830WP.53012359On the marketKinderpflaster DinoformPP06830WP.20022396On the marketKinderpflaster EinhornformPP06830WP.20022396On the marketLekerianAB-Pflasterbriefchen LottaPP06830WP.20022396On the marketNo 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.