- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Apr 18, 2024
B-06951727602012CHANGKUN is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Shenzhen Changkun Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06951727602012CK-W132(01)06951727602012
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z1203020501NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES4 warnings recorded — scroll inside the panel to see all entries.
Hypertension can’t be judged by the measured value through this product. The value is used for monitoring blood pressure. Self-diagnosis of measurement results and self-treatment are dangerous. Contact your physician about the measured value.
Do not use the device on the injured wrist under medical treatment. Operate the device only as intended. Do not use the device for any other purpose. Do not disassemble or attempt to repair the unit or components.
If battery fluid should get in your eyes, immediately rinse with plenty of clean water. Contact a physician immediately.
Please do not use any unmatched AC adapter. Do not plug or unplug the power cord into the electrical outlet with wet hands.
CN-MF-000024514CN21/70011Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
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 →No certificate specifically references this device's Basic UDI-DI.
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.