Identity
- Trade Name
- HAEMODIALYSIS EQUIPMENT EUDAMEDDBB-EXA EUDAMED
- Device Name
- Hemodialysis Equipment EUDAMEDHemodialysis Equipment DBB-EXA EUDAMED
- Model / Reference
- DBB-EXA EUDAMEDDO-F371-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987671041616 EUDAMED04987671600004 EUDAMED
- Basic UDI-DI
- B-04987671041616 EUDAMED4987671HD-EqA2P EUDAMED
- Direct Marketing DI
- 04987671600004 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
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
Haemodialysis Equipment by Nikkiso Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04987671041616 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04987671041616 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nikkiso Co., Ltd.
- EUDAMED SRN
- JP-MF-000019276
- Authorised Representative
- NIKKISO Medical Europe GmbH DE-AR-000042794
Sources (2)
- EUDAMED 5041470b-7fb5-4b73-abbf-b69646dca930 61 fields · synced Jul 16, 2026
- EUDAMED 28c0988c-d450-401e-a69d-a5b78224106d 61 fields · synced Jul 10, 2026