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Q010699
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 16187Model Multilayer ML-0M1-SHT 89×71×14
Identity
- Trade Name
- Q010699 EUDAMEDYUCERA FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- Multilayer ML-0M1-SHT 89×71×14 EUDAMED16187 EUDAMEDML-0M1-SHT FDA UDI
Identifiers
- Catalog Number
- SHT 89×71×14mm FDA UDI
- Primary DI / UDI-DI
- 06942053539264 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06942053539264 EUDAMED
- FDA Product Code
- PKJ FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDN FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Q010699 by Shenzhen Yurucheng Dental Materials Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942053539264 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yurucheng Dental Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000011505
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED d1791335-4dd5-4aca-959f-5258fc46a00f 61 fields · synced Jun 19, 2026
- FDA UDI dc171ee8-aeec-4292-b940-34fb43be248f 36 fields · synced May 30, 2026