Intraoral Digital Imaging Sensor
by Changzhou Sifary Medical Technology Co., Ltd. United States EUDAMED
Ref 6980178Model NanoPix-M Pro 1, NanoPix-M Pro 1.4, NanoPix-M Pro 2, VSensor-M Pro 1, VSensor-M Pro 1.4, VSensor-M Pro 2
EMDN Z1103040102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697259778EN008N5 | 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
- Model / Reference
- NanoPix-M Pro 1, NanoPix-M Pro 1.4, NanoPix-M Pro 2, VSensor-M Pro 1, VSensor-M Pro 1.4, VSensor-M Pro 2, 6980178
- Primary DI / UDI-DI
- 06941877828813
- Basic UDI-DI
- 697259778EN008N5
- 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 (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 06941877828813|697259778EN008N5