Identity
- Trade Name
- Alpha Active 4 EUDAMED
- Device Name
- ALPHA ACTIVE 3 PUMP EUDAMED
- Model / Reference
- 648305BG EUDAMED648315RO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055982789042 EUDAMED
- Basic UDI-DI
- 5060693520020VD EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Alpha Active 4 by Arjohuntleigh AB — 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 | 5060693520020VD | Class IIa | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (1)
- EUDAMED 582683a1-d36f-4dd1-98f1-8b3549d64951 61 fields · synced Jun 18, 2026