Identity
- Device Name
- Skin Electrical Conductance Meters EUDAMED
- Model / Reference
- HRA-II EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HRA-IIE9 EUDAMED
- Basic UDI-DI
- B-HRA-IIE9 EUDAMED
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Skin Electrical Conductance Meters by Qinhuangdao Huisianpu Medical Systems Inc — 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-HRA-IIE9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Qinhuangdao Huisianpu Medical Systems Inc
- EUDAMED SRN
- CN-MF-000011586
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 98f7f716-5e51-4e60-b8f3-cb63c6d2b5a8 61 fields · synced Oct 7, 2026