- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Aug 11, 2026
697442359IWN45P6WP0046 STD is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Koolcare Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974423594191WP0046 STD(01)06974423594191
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120602PHYSIOTHERAPY EQUIPMENT1 warning recorded — scroll inside the panel to see all entries.
This product can cause burns. -Keep out of reach of children, infants and animals. Do not microwave. l This product is disposable. l This product may cause itchy skin, skin pinkness or minor skin burn for people with sensitive skin or misused. l Do not wear while sleeping. l Check skin frequently (around every one hour) during use . l Ask a doctor before use if you have diabetes, poor circulation or heart disease, rheumatoid arthritis or are pregnant . l If you find irritation or a burn, remove product immediately. l Each cell contains iron which can be harmful if swallowed. If swallowed, rinse mouth with water and call a Poison Control center right. l If heat pad contents come in contact with your skin or eyes, rinse right away with water. Never heat product in microwave or attempt to reheat as heat pads could catch fire. l Dispose of waste according to local regulations. l The temperature and heating time of this product will vary depending on the use environment, and the heating effect may be affected when the ambient temperature is too low.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
CN-MF-000017687The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
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 →Certificate health across this manufacturer's portfolio.
HZ 2159986-1IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
No certificate specifically references this device's Basic UDI-DI.