← Back to catalogue
PMMA Block
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Shade:Pink A/VITA16 COLORS; Spec:98*30mm; Net Weight:252gModel Single Layer; Multi-Layer 510(k) K223706
Identity
- Trade Name
- PMMA Block EUDAMED
- Device Name
- PMMA BLOCK EUDAMED
- Model / Reference
- Single Layer; Multi-Layer EUDAMEDShade:Pink A/VITA16 COLORS; Spec:98*30mm; Net Weight:252g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975187618192 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223706 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6975187612aSZKQG | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huliang(Shanghai)Bio-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013327
- FDA Applicant
- Huliang(Shanghai) Bio-Tech Co., Ltd.
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (2)
- EUDAMED d307607d-3e10-4ffb-a796-b63f10c99ab6 85 fields · synced Jun 18, 2026
- FDA 510(k) K223706 1 fields · synced May 18, 2026