Identity
- Trade Name
- CHANGKUN EUDAMED
- Device Name
- Arm Electronic Sphygmomanometer EUDAMED
- Model / Reference
- CK-A158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951727602623 EUDAMED
- Basic UDI-DI
- B-06951727602623 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Changkun by Shenzhen Changkun Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06951727602623 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Changkun Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024514
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (1)
- EUDAMED 2ba072a6-7ff9-4b64-83c7-9150a4b55920 61 fields · synced May 23, 2026