← Back to catalogue
Hemodialysis Equipment
EUDAMEDClass IIb (EU MDR)
Ref S01020200001Model Aide1, Aide1 SE, Aide1 Pro, Aide1 Max, Aide2, Aide2 Pro, Aide3, Aide3 Pro
Identity
- Trade Name
- Hemodialysis Equipment EUDAMED
- Device Name
- Hemodialysis Equipment EUDAMED
- Model / Reference
- Aide1, Aide1 SE, Aide1 Pro, Aide1 Max, Aide2, Aide2 Pro, Aide3, Aide3 Pro EUDAMEDS01020200001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976533600069 EUDAMED
- Basic UDI-DI
- 69765336000001ZS EUDAMED
- Direct Marketing DI
- 06976533600069 EUDAMED
- EMDN Code
- Z12090201 HAEMODIALYSIS EQUIPMENT 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hemodialysis Equipment by Guangzhou Oci Medical Devices Co., Ltd. — 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 | 69765336000001ZS | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangzhou Oci Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000036303
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 952cadeb-ce98-45ce-b11f-498100d9479a 61 fields · synced Jun 18, 2026