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Z-Ems Zionic Pro Max Hp 4
EUDAMEDClass IIb (EU MDR)
Ref A498/4Model Z-EMS ZIONIC PRO MAX HP 4
Identity
- Device Name
- Z-EMS ZIONIC PRO MAX HP 4 EUDAMED
- Model / Reference
- Z-EMS ZIONIC PRO MAX HP 4 EUDAMEDA498/4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436601291400 EUDAMED
- Basic UDI-DI
- 843660129ZPEMSHP4H6 EUDAMED
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Z-Ems Zionic Pro Max Hp 4 by Termosalud, S.L. — Class IIb — 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 | 843660129ZPEMSHP4H6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Termosalud, S.L.
- EUDAMED SRN
- ES-MF-000019177
Sources (1)
- EUDAMED 223b1dbb-7bdc-45ed-87f4-bbae1e9cc655 61 fields · synced Jun 20, 2026