Silicon Impression Material
by Zhengzhou Huaer Electro-optics Technology Co, Ltd.
Ref 06974041280636Model HR-ZIP01,HR-ZIP02,HR-ZIP03,HR-ZIP04,HR-ZIP05,HR-ZIP06,HR-ZIP07,HR-ZIP08,HR-ZIP09,HR-ZIK01,HR-ZIK02,HR-ZIK03,HR-ZIK04,HR-ZIK05
Active
CE MDR 510(k)
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69740412806367N 06974041280636 | Date13 May 2025 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK201483 | Date8 Oct 2020 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Device Name
- Silicon Impression Material
- Model / Reference
- HR-ZIP01, HR-ZIP02, HR-ZIP03, HR-ZIP04, HR-ZIP05, HR-ZIP06, HR-ZIP07, HR-ZIP08, HR-ZIP09, HR-ZIK01, HR-ZIK02, HR-ZIK03, HR-ZIK04, HR-ZIK05, 06974041280636
- Primary DI / UDI-DI
- 06974041280636
- Basic UDI-DI
- 69740412806367N
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- EU 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