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UltraPrint-Dental Surgical Guide UV
EUDAMEDFDA UDIClass I (EU MDR)
Ref MA.002.230Model Surgical Guide UV
Identity
- Trade Name
- UltraPrint-Dental Surgical Guide UV EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- UltraPrint-Dental Surgical Guide UV, 160g/bottle FDA UDI
- Model / Reference
- Surgical Guide UV EUDAMEDMA.002.230 EUDAMED1.0 FDA UDI
- Description
- UltraPrint-Dental Surgical Guide UV, 160g/bottle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971437941249 EUDAMEDFDA UDI
- Basic UDI-DI
- 697143794SGUVSU EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0102050199,Q010699 EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
UltraPrint-Dental Surgical Guide UV by Guangzhou Heygears Imc.inc — 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 | 697143794SGUVSU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Heygears Imc.inc
- EUDAMED SRN
- CN-MF-000010624
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f7fba6d2-f509-4e92-b7e1-2a6408eff6c4 61 fields · synced Jul 16, 2026
- FDA UDI 846e3b4f-4321-4abf-bb05-bc45f8e35b7a 33 fields · synced May 30, 2026