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PMMA Block
EUDAMEDClass IIa (EU MDR)
Ref Shade:A3.5; Spec:AG*18mm; Net Weight:121gModel Single Layer; Multi-Layer
Identity
- Trade Name
- PMMA Block EUDAMED
- Device Name
- PMMA BLOCK EUDAMED
- Model / Reference
- Single Layer; Multi-Layer EUDAMEDShade:A3.5; Spec:AG*18mm; Net Weight:121g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975187617096 EUDAMED
- Basic UDI-DI
- 6975187612aSZKQG EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
PMMA Block by Huliang(Shanghai)Bio-Tech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6975187612aSZKQG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Huliang(Shanghai)Bio-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013327
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (1)
- EUDAMED ac8ed848-0771-4a16-9c17-b795c4b3ae4c 61 fields · synced Jun 9, 2026