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Intraoral Scanner
EUDAMEDFDA UDIClass I (EU MDR)
Ref HCE-IS-130Model HCE-IS-130,HCE-IS-300,HCE-IS-500,HCE-IS-800
Identity
- Trade Name
- Intraoral Scanner EUDAMEDFDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intraoral Scanner EUDAMED
- Model / Reference
- HCE-IS-130,HCE-IS-300,HCE-IS-500,HCE-IS-800 EUDAMEDHCE-IS-130 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977274260253 EUDAMEDFDA UDI
- Basic UDI-DI
- 697727426scannerPJ EUDAMED
- Direct Marketing DI
- 06977274260253 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Intraoral Scanner by Changsha Honchon Technology Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697727426scannerPJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Changsha Honchon Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000044568
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED 5fe749f8-1701-4c51-ba81-6a5f36caecb9 61 fields · synced Jun 19, 2026
- FDA UDI 885938ed-a194-49de-bcc7-47b4a3cbf2ee 32 fields · synced May 30, 2026