Dialysis Kit
by ITL Asia Pacific Sdn. Bhd. Malaysia EUDAMED
Ref 061PC05014A
EMDN F0399
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955524040DP1SEF | Date31 Jul 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dialysis Pack
- Model / Reference
- 061PC05014A
- Primary DI / UDI-DI
- 09555240403827, 09555240407153
- Basic UDI-DI
- 955524040DP1SEF, 955524040DPSNE
- EMDN Code
- F0399 Dialysis kits - other
- Device Class
- Class I
- Medical Purpose
- The procedure pack provides the necessary items, which are mutually compatible for skin prep prior to the commencement of haemodialysis.
Manufacturer details
- EUDAMED SRN
- MY-MF-000001570
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Itl Asia Pacific Sdn. Bhd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 462ba313-bf8f-4900-a6d9-32fb8ed7f744
- EUDAMED 7f779e93-0eff-4690-bc3e-2ad1ba1b1361