Identity
- Trade Name
- PORCELAIN SILANE EUDAMED
- Device Name
- Ceramic Surface Treatments EUDAMED
- Model / Reference
- 400083SA EUDAMED400083GR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115053913 EUDAMED07290115050899 EUDAMED
- Basic UDI-DI
- 729011505400084AZ EUDAMED
- Unit of Use DI
- 07290115051650 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Category: Dental appliance fabrication material, ceramic
Porcelain Silane by B.J.M. Laboratories Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 729011505400084AZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED ad46026f-eadc-4e26-b429-187c6e5114a2 61 fields · synced Jul 20, 2026
- EUDAMED 3d23cb0b-5083-47b6-bde5-9f5ea0c1f9d6 61 fields · synced May 18, 2026