Haemodialysis equipment
by Guangdong Biolight Meditech Co., Ltd United States EUDAMED
Ref D800HModel D800Plus, D800H, D800S, D50 EMDN Z12090201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number693256232000144 | Date25 Jun 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- D800Plus, D800H, D800S, D50
- Primary DI / UDI-DI
- 06932562300493
- Basic UDI-DI
- 693256232000144
- EMDN Code
- Z12090201 Haemodialysis equipment
- Device Class
- Class IIb
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000006333
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Guangdong Biolight Meditech Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED f025cd54-20fc-40c5-8f8f-b03507b6b2a8