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Alpha Active 3
EUDAMEDClass I (EU MDR)
Ref 648343WModel 636C01SRef 648305TRModel 648305BGRef 648343Ref 648325Ref 648301UKRef 648342WRef 648305NORef 648305DKRef 648305SIRef 648304ATRef 648305RO
Identity
- Trade Name
- Alpha Active 3 EUDAMED
- Device Name
- AURALIS SEAT CUSHION EUDAMEDALPHA ACTIVE 3 PUMP EUDAMED
- Model / Reference
- 636C01S EUDAMED648343W EUDAMED648305BG EUDAMED648305TR EUDAMED648343 EUDAMED648325 EUDAMED648301UK EUDAMED648342W EUDAMED648305NO EUDAMED648305DK EUDAMED648305SI EUDAMED648304AT EUDAMED648305RO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055982789356 EUDAMED05056097340968 EUDAMED05055982781046 EUDAMED05055982784719 EUDAMED05055982784627 EUDAMED05056097336985 EUDAMED05055982789387 EUDAMED05055982780926 EUDAMED05055982780919 EUDAMED05056097346892 EUDAMED05059441139621 EUDAMED05056097336886 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 EUDAMEDTürkiye EUDAMEDIreland EUDAMEDBulgaria EUDAMEDNorway EUDAMEDDenmark EUDAMEDSlovenia EUDAMEDRomania 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 3 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 65385056-149b-4b35-82d9-d02b4acc9dfc 61 fields · synced Aug 3, 2026
- EUDAMED 929e9b5d-f8f9-4f0c-949c-68e228fa4c55 61 fields · synced May 16, 2026
- EUDAMED 334d6ca7-1e3d-4fe7-9313-b53782a7ba53 61 fields · synced May 17, 2026
- EUDAMED 3fa88fbe-127a-4911-89fe-0853be4cd807 61 fields · synced May 17, 2026
- EUDAMED 39a3749e-a594-4397-89d8-90ada0758286 61 fields · synced May 17, 2026
- EUDAMED 1e8f2d86-e625-4ac4-8dbb-a320b49b1dfe 61 fields · synced May 17, 2026
- EUDAMED c3c11130-592f-404b-af62-3e391408c1de 61 fields · synced May 17, 2026
- EUDAMED 6f29eed8-3b0d-44cf-a3de-3e6a5383b39f 61 fields · synced May 17, 2026
- EUDAMED 5aa4326a-ecf8-4d54-bcba-0cc5eb8aafc7 61 fields · synced May 17, 2026
- EUDAMED a7679b07-529b-44b8-85ff-ce494579cce0 61 fields · synced May 17, 2026
- EUDAMED 2dedbe55-5621-4d97-b667-d0126a3f3cfb 61 fields · synced May 17, 2026
- EUDAMED 574d7e48-40ea-4ad8-b60d-8c5ccfaee913 61 fields · synced May 18, 2026