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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
- 06976533600052 EUDAMED06976533600083 EUDAMED06976533600021 EUDAMED06976533600038 EUDAMED06976533600014 EUDAMED06976533600045 EUDAMED06976533600076 EUDAMED
- Basic UDI-DI
- 69765336000001ZS EUDAMED
- Direct Marketing DI
- 06976533600052 EUDAMED06976533600083 EUDAMED06976533600021 EUDAMED06976533600038 EUDAMED06976533600014 EUDAMED06976533600045 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 |
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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 (7)
- EUDAMED 56e668e0-b25a-4c85-9a05-48f4fe84c821 61 fields · synced Oct 6, 2026
- EUDAMED 7e5e0eb7-aca2-4bc7-89bf-8809c22a9215 61 fields · synced May 17, 2026
- EUDAMED 3306fd35-e8e4-427a-a87d-219267ff99d1 61 fields · synced May 17, 2026
- EUDAMED 373431d5-1925-446d-9b8f-7387b8b3f401 61 fields · synced May 17, 2026
- EUDAMED 4b1b46eb-dd90-4d8b-bf9b-727deea62e1b 61 fields · synced May 17, 2026
- EUDAMED 765c19fc-5274-4fc6-ba4c-f22698722286 61 fields · synced May 17, 2026
- EUDAMED be9b1253-6bf6-48a6-b1b4-129d61a55522 61 fields · synced May 19, 2026