Vacuum Forming Sheet
by Zhengzhou Huaer Electro-optics Technology Co, Ltd. EUDAMED
Active
Ref 06974041280681, 06974041280674Model HR-ZPS01,HR-ZPS02,HR-ZPS03,HR-ZPS04,HR-ZPS05,HR-ZPR01,HR-ZPR02,HR-ZPR03,HR-ZPR04,HR-ZPR05, HR-ZTS01,HR-ZTD01,HR-ZTT01,HR-ZTT02
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697404128HRVF01L9 | Date21 May 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Vacuum Forming Sheet
- Model / Reference
- HR-ZPS01, HR-ZPS02, HR-ZPS03, HR-ZPS04, HR-ZPS05,HR-ZPR01, HR-ZPR02, HR-ZPR03, HR-ZPR04, HR-ZPR05, 06974041280681, HR-ZTS01, HR-ZTD01, HR-ZTT01, HR-ZTT02, 06974041280674
- Primary DI / UDI-DI
- 06974041280681, 06974041280674
- Basic UDI-DI
- 697404128HRVF01L9, 697404128HZPR01PK
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000003166
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties
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