Identity
- Trade Name
- Kidney Assist™ EUDAMED
- Device Name
- Organ Preservation Devices EUDAMED
- Model / Reference
- 21.101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719925460685 EUDAMED
- Basic UDI-DI
- 871992546100M2 EUDAMED
- EMDN Code
- C0399 CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kidney Assist™ by Xvivo B.v. — Class IIb — 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 | 871992546100M2 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xvivo B.v.
- EUDAMED SRN
- NL-MF-000018307
Sources (1)
- EUDAMED 39ba1c05-9399-443c-99cc-b9afbb7f3756 61 fields · synced Jun 20, 2026