Identity
- Trade Name
- Multichannel Electrocardiograph EUDAMED
- Device Name
- Multichannel Electrocardiograph EUDAMED
- Model / Reference
- PHS-U10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897139610011 EUDAMED
- Basic UDI-DI
- 489713961001L4 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Multichannel Electrocardiograph by PhysioSign Hong Kong Medical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489713961001L4 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PhysioSign Hong Kong Medical Limited
- EUDAMED SRN
- CN-MF-000041466
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED 81b668e5-be29-4cff-afb1-357164bddf3f 61 fields · synced Jun 18, 2026