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Alpha Active 4
EUDAMEDClass I (EU MDR)
Ref 648326WModel 636C01SRef 648315HUModel 648305BGRef 648326Ref 648334WRef 648314ATRef 648315SERef 648315GRRef 648315BGRef 648315DKRef 648315LTRef 648315HRRef 648315CS
Identity
- Trade Name
- Alpha Active 4 EUDAMED
- Device Name
- AURALIS SEAT CUSHION EUDAMEDALPHA ACTIVE 3 PUMP EUDAMED
- Model / Reference
- 636C01S EUDAMED648326W EUDAMED648305BG EUDAMED648315HU EUDAMED648326 EUDAMED648334W EUDAMED648314AT EUDAMED648315SE EUDAMED648315GR EUDAMED648315BG EUDAMED648315DK EUDAMED648315LT EUDAMED648315HR EUDAMED648315CS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055982789424 EUDAMED05055982789110 EUDAMED05055982784740 EUDAMED05055982789400 EUDAMED05059441139638 EUDAMED05055982780988 EUDAMED05055982789073 EUDAMED05055982789103 EUDAMED05055982780964 EUDAMED05055982789134 EUDAMED05056097346946 EUDAMED05055982788892 EUDAMED
- Basic UDI-DI
- 5060693520136VZ EUDAMED5060693520020VD EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMEDZ12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria EUDAMEDHungary EUDAMEDSweden EUDAMEDGreece EUDAMEDBulgaria EUDAMEDDenmark EUDAMEDLithuania EUDAMEDCroatia EUDAMEDCzechia 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 I — 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 | 5060693520136VZ | Class I | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (12)
- EUDAMED 1a5b5c1f-a708-45af-977b-40a5b1ede8e8 61 fields · synced Sep 17, 2026
- EUDAMED ebb46daf-951f-4109-b906-763bf0be22c2 61 fields · synced May 16, 2026
- EUDAMED 9ea54d14-631e-43ec-91a1-54adf2d88160 61 fields · synced May 16, 2026
- EUDAMED eddac95e-63ca-46d3-82ef-a3f36e1b3f2e 61 fields · synced May 17, 2026
- EUDAMED 6b4c9a3c-7b40-47ba-b0e4-925cb0181115 61 fields · synced May 17, 2026
- EUDAMED e393c8f9-95bc-463a-aaab-aa79b86afee4 61 fields · synced May 17, 2026
- EUDAMED 7ea9f1ef-7c7a-42c3-b8e3-9f62b816d1d7 61 fields · synced May 17, 2026
- EUDAMED d6958f42-ac05-4493-b8e8-7bf928d3e813 61 fields · synced May 17, 2026
- EUDAMED 1e98aa6b-c53b-4761-babd-3ef58260a10b 61 fields · synced May 18, 2026
- EUDAMED 8e315938-9f00-47fe-9e21-a87a60264605 61 fields · synced May 18, 2026
- EUDAMED f435bb6c-c775-4efb-b0dd-6aa97055de79 61 fields · synced May 18, 2026
- EUDAMED 93df2782-d45f-4ab7-857b-968e3ea95990 61 fields · synced May 19, 2026