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System 2000 - Primo
EUDAMEDClass I (EU MDR)
Ref AP02801EU1011Model AL21000-EURef AP01811GB1010Ref AP31810GB2010
Identity
- Trade Name
- System 2000 - Primo EUDAMED
- Device Name
- Medical Baths EUDAMED
- Model / Reference
- AL21000-EU EUDAMEDAP02801EU1011 EUDAMEDAP01811GB1010 EUDAMEDAP31810GB2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055982712026 EUDAMED05055982711012 EUDAMED05055982715102 EUDAMED
- Basic UDI-DI
- 5060693520044VT EUDAMED
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDIreland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hydrotherapy bath/tank
System 2000 - Primo by Arjohuntleigh AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hydrotherapy bath/tank.
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- Haltegriff Edelstahl, 40 cm — Ludwig Bertram GmbH · Class I
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 | 5060693520044VT | Class I | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (3)
- EUDAMED cf8ca3be-4348-479c-ab88-61acb0881ebb 61 fields · synced Sep 30, 2026
- EUDAMED a34c884b-867e-48e7-9cae-c92ceb2226eb 61 fields · synced Sep 17, 2026
- EUDAMED 60eec5d3-db1c-479d-a929-b29797c6b63e 61 fields · synced Sep 30, 2026