Identity
- Trade Name
- Dialysis Kit - OFF EUDAMED
- Device Name
- Dialysis Pack EUDAMED
- Model / Reference
- 061PC05041A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240405234 EUDAMED09555240407191 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 - OFF 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 (2)
- EUDAMED 870e3056-cd2b-42ff-880e-56ca8c8f3cd4 61 fields · synced Jul 20, 2026
- EUDAMED 56712d41-575c-42a0-b7a2-d775af6a28f3 61 fields · synced Jul 20, 2026