Identity
- Trade Name
- HAEMODIALYSIS EQUIPMENT EUDAMED
- Device Name
- Hemodialysis Equipment EUDAMED
- Model / Reference
- DBB-EXA ES EUDAMED3313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987671041678 EUDAMED
- Basic UDI-DI
- B-04987671041678 EUDAMED
- EMDN Code
- Z12090201 HAEMODIALYSIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Haemodialysis Equipment by Nikkiso Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04987671041678 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nikkiso Co., Ltd.
- EUDAMED SRN
- JP-MF-000019276
- Authorised Representative
- NIKKISO Medical Europe GmbH DE-AR-000042794
Sources (1)
- EUDAMED c03ff64a-5280-43df-83ff-d4c6c8cb6873 61 fields · synced Jun 17, 2026