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Kidney Assist™ Perfusion Set
EUDAMEDClass IIa (EU MDR)
Ref 21.401
by Xvivo B.v.
Identity
- Trade Name
- Kidney Assist™ Perfusion Set EUDAMED
- Device Name
- Organ Preservation Sterile Perfusion Sets EUDAMED
- Model / Reference
- 21.401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719925460722 EUDAMED
- Basic UDI-DI
- 871992546400MH EUDAMED
- EMDN Code
- C0399 CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Kidney Assist™ Perfusion Set by Xvivo B.v. — Class IIa — 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 | 871992546400MH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xvivo B.v.
- EUDAMED SRN
- NL-MF-000018307
Sources (1)
- EUDAMED b8d92acd-b4c1-4306-b91b-b9e8530cafd0 61 fields · synced Jun 18, 2026