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Changkun
EUDAMEDClass IIa (EU MDR)
Ref CK-A156Ref CK-A138Ref CK-W356Ref CK-W118Ref CK-T1503Ref CK-W175Ref CK-W355Ref CK-A168Ref CK-T1501
Identity
- Trade Name
- CHANGKUN EUDAMED
- Device Name
- Arm Electronic Sphygmomanometer EUDAMEDWrist Electronic Sphygmomanometer EUDAMEDInfrared Thermometer EUDAMED
- Model / Reference
- CK-A156 EUDAMEDCK-A138 EUDAMEDCK-W356 EUDAMEDCK-W118 EUDAMEDCK-T1503 EUDAMEDCK-W175 EUDAMEDCK-W355 EUDAMEDCK-A168 EUDAMEDCK-T1501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951727601091 EUDAMED06951727601077 EUDAMED06951727602579 EUDAMED06951727602517 EUDAMED06951727602616 EUDAMED06951727602548 EUDAMED06951727602562 EUDAMED06951727602005 EUDAMED06951727602593 EUDAMED
- Basic UDI-DI
- B-06951727601091 EUDAMEDB-06951727601077 EUDAMEDB-06951727602579 EUDAMEDB-06951727602517 EUDAMEDB-06951727602616 EUDAMEDB-06951727602548 EUDAMEDB-06951727602562 EUDAMEDB-06951727602005 EUDAMEDB-06951727602593 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMEDV0301010202 NON-CONTACT DIGITAL THERMOMETERS 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-06951727601091 | 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 (9)
- EUDAMED f0f57652-b1c5-43af-9f99-f0359ae7f881 61 fields · synced Aug 4, 2026
- EUDAMED a250d71d-e348-47ef-a115-84b2e8f6cd29 61 fields · synced May 16, 2026
- EUDAMED 330835d4-76cf-49a1-8aaa-ce819d2d1566 61 fields · synced May 17, 2026
- EUDAMED 2b4346f4-28ea-4ba2-8a27-54aaea780516 61 fields · synced May 17, 2026
- EUDAMED ef94511e-b116-4664-bdb6-77a3cd01f38c 61 fields · synced May 17, 2026
- EUDAMED fae37330-daaa-48ba-807d-3cdf1c4fde8a 61 fields · synced May 18, 2026
- EUDAMED ba96681f-351b-4111-bb73-4b08c7d0a7c7 61 fields · synced May 18, 2026
- EUDAMED 4a331b9b-5533-4c2a-ba1a-b6d4fbd7c437 61 fields · synced May 18, 2026
- EUDAMED 6e4fcd98-2045-4f4b-b5f0-2cff36cbcded 61 fields · synced Jul 17, 2026