Identity
- Trade Name
- Dialysis Kit EUDAMED
- Device Name
- Dialysis Pack EUDAMED
- Model / Reference
- 061PC05017A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240404732 EUDAMED
- Basic UDI-DI
- 955524040DP1SEF EUDAMED
- EMDN Code
- F0399 DIALYSIS KITS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
Yes
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
Dialysis Kit by Itl Asia Pacific Sdn. Bhd. — 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 | 955524040DP1SEF | Class I | Active |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 02ea89e5-30a1-4307-b554-ebe2e9610ba2 61 fields · synced Jun 19, 2026