Hefei Meyer Optoelectronic Technology Inc.
China Last updated 25 Oct 2026
- Devices
- 13
- Registries
- EUDAMEDGUDIDFDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Intraoral Scanner Ref mOS MyScan 5
Intraoral Scanner Tip Ref TIP-5S
Meyer mDX-15Pro-B50 Ref mDX-15Pro-B50
Meyer mDX-15Pro-K10 Ref mDX-15Pro-K10
Meyer mDX-15Pro-Y30 Ref mDX-15Pro-Y30
Meyer mDX-15Plus-Y50S Ref mDX-15Plus-Y50S
Intraoral Scanner Tip Ref TIP-5L
Mobile Computed Tomography X-ray System Ref mDX-22explorer
2D Panoramic Dental Imaging System Ref SS-X9010DPro-2DE
Intraoral Scanner Tip Ref TIP-2
Intraoral Scanner Ref mOS MyScan
Dental Cone-beam Computed Tomography Ref SS-X9010DPro-3DE
EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 2 certificates
- G10 104441 0005 Issued
Quality management system EU MDR
- Issued
- 8 Jan 2025
- Expires
- 7 Jan 2030
- G15 104441 0006 Issued
Quality management system EU MDR
- Issued
- 9 Jul 2026
- Expires
- 7 Jan 2030
Related companies
Authorised representatives
- MedPath GmbH DE
Notified bodies
What Hefei Meyer Optoelectronic Technology Inc. makes
Hefei Meyer Optoelectronic Technology Inc. manufactures dental imaging equipment, including 2D panoramic and cone-beam computed tomography (CBCT) systems for intraoral and extraoral use. Their portfolio also includes intraoral scanner tips and preformed, single-use temporary dental implant suprastructures.
These devices are classified as Class I and Class IIb under EU regulations and are registered in the EUDAQMED database. The company operates from China.
Frequently asked questions
How many devices does Hefei Meyer Optoelectronic Technology Inc. have in the registry?
The registry currently lists 13 devices for Hefei Meyer Optoelectronic Technology Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hefei Meyer Optoelectronic Technology Inc.'s devices?
Among its 13 most recently registered devices, Hefei Meyer Optoelectronic Technology Inc. has devices listed in EUDAMED (12 devices), FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hefei Meyer Optoelectronic Technology Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Hefei Meyer Optoelectronic Technology Inc.'s devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Hefei Meyer Optoelectronic Technology Inc.?
EUDAMED lists 2 certificates for Hefei Meyer Optoelectronic Technology Inc. (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 2026-07-09.
What are the newest devices from Hefei Meyer Optoelectronic Technology Inc. in the registry?
The most recently registered devices listed for Hefei Meyer Optoelectronic Technology Inc. include Intraoral Scanner, Intraoral Scanner Tip, Meyer mDX-15Pro-B50 and Meyer mDX-15Pro-K10.
Information
- Address
- No.668 Wangjiang West Road, High& New Tech. Industry Development Zone, Hefei, China
- Website
- meyerop.com
- [email protected]
- PRRC contact
- Zixuan Zhao
- EUDAMED SRN
- CN-MF-000029043
- FDA FEI number
- 3013510497
- DUNS number
- 530006691