System 2000 - Primo
by ArjoHuntleigh AB 669 variants
Ref AP33810EU1001Model AL21000-EU
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5060693520044VT 05055982718691 | Date2 Mar 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Medical Baths
- Model / reference
- AL21000-EU, AP33810EU1001
- Primary DI / UDI-DI
- 05055982718691
- Basic UDI-DI
- 5060693520044VT
- EMDN code
- Y093399 Washing, bathing and showering devices - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- SE-MF-000000696
Other devices from Arjohuntleigh AB
Properties
Other properties (13)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Incorporates a medicinal substance: No