Medical Laser Printer SM6000
by Smart Health Biotech (Guangxi) Co., Ltd. China EUDAMED
Ref 58195 70049Model SM6000、SM8000
EMDN Z11079005
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69263491SRDPYC | Date13 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Laser Printer
- Model / Reference
- SM6000、SM8000, 58195 70049
- Primary DI / UDI-DI
- 06958195700493
- Basic UDI-DI
- 69263491SRDPYC
- EMDN Code
- Z11079005 Printing machines
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000040855
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: 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 36000d1b-f451-46fc-af64-738e26399b51