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Dialysis Kit
EUDAMEDClass I (EU MDR)
Ref 061PC05015ARef 061PC05014ARef 061PC05017ARef 061PC05016A
Identity
- Trade Name
- Dialysis Kit EUDAMED
- Device Name
- Dialysis Pack EUDAMED
- Model / Reference
- 061PC05015A EUDAMED061PC05014A EUDAMED061PC05017A EUDAMED061PC05016A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240405371 EUDAMED09555240403827 EUDAMED09555240407177 EUDAMED09555240407153 EUDAMED09555240407207 EUDAMED
- Basic UDI-DI
- 955524040DP1SEF EUDAMED955524040DPSNE EUDAMED
- EMDN Code
- F0399 DIALYSIS KITS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The procedure pack provides the necessary items, which are mutually compatible for skin prep prior to the commencement of haemodialysis. 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 (5)
- EUDAMED a522c25f-3f08-404e-9052-bee4d2b9a6e2 61 fields · synced Aug 2, 2026
- EUDAMED 462ba313-bf8f-4900-a6d9-32fb8ed7f744 61 fields · synced May 17, 2026
- EUDAMED aefa8500-58ab-4c7b-8c4f-eeac6938675e 61 fields · synced Jul 12, 2026
- EUDAMED 7f779e93-0eff-4690-bc3e-2ad1ba1b1361 61 fields · synced Jul 16, 2026
- EUDAMED 5ac86ff2-b0f5-44af-b698-32a0b7c5fbe7 61 fields · synced Jul 29, 2026