Identity
- Trade Name
- CB11 B3 EUDAMED
- Device Name
- Temporary CB Resin EUDAMED
- Model / Reference
- CB11 EUDAMED0752 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975338700752 EUDAMED
- Basic UDI-DI
- 697533870CB11JA EUDAMED
- Direct Marketing DI
- 06975338700752 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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, resin
Cb11 B3 by Hangzhou SHINING3D Dental Technology Co., 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 | 697533870CB11JA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou SHINING3D Dental Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033456
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 48b5358e-3b81-479e-83b7-b2143801806e 61 fields · synced Oct 6, 2026