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Haemodialysis equipment
EUDAMEDClass IIb (EU MDR)
Ref D800SModel D800Plus, D800H, D800S, D50
Identity
- Trade Name
- Haemodialysis equipment EUDAMED
- Device Name
- Haemodialysis equipment EUDAMED
- Model / Reference
- D800Plus, D800H, D800S, D50 EUDAMEDD800S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300486 EUDAMED
- Basic UDI-DI
- 693256232000144 EUDAMED
- EMDN Code
- Z12090201 HAEMODIALYSIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Haemodialysis equipment by Guangdong Biolight Meditech 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 | 693256232000144 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 61026847-7ade-4892-ba3d-c650bacd08c2 61 fields · synced Jun 17, 2026