ntraoral Digital Imaging Sensor
by Changzhou Sifary Medical Technology Co., Ltd. United States EUDAMED
Ref 6980170Model NanoPix Pro 1, NanoPix Pro 1.4, NanoPix Pro 2, VSensor Pro 1, VSensor Pro 1.4, VSensor Pro 2
EMDN Z1103040102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697259778EN007N3 | Date6 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 6126956CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 31 Mar 2025
- Expires
- 1 Aug 2027
- Reason
- Change approved
Specification
- Device Name
- Intraoral Digital Imaging Sensor
- Model / Reference
- NanoPix Pro 1, NanoPix Pro 1.4, NanoPix Pro 2, VSensor Pro 1, VSensor Pro 1.4, VSensor Pro 2, 6980170
- Primary DI / UDI-DI
- 06941877828738
- Basic UDI-DI
- 697259778EN007N3
- EMDN Code
- Z1103040102 Equipment for digital endoral radiology
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000010405
- Authorised representative
- Caretechion GmbH DE-AR-000005946
Other devices from Changzhou Sifary Medical Technology Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06941877828738|697259778EN007N3