Identity
- Trade Name
- CB11 A3.5 EUDAMED
- Device Name
- Temporary CB Resin EUDAMED
- Model / Reference
- CB11 EUDAMED0721 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975338700721 EUDAMED
- Basic UDI-DI
- 697533870CB11JA EUDAMED
- Direct Marketing DI
- 06975338700721 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
Cb11 A3.5 by Hangzhou SHINING3D Dental Technology 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 | 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 a972f80b-1fe2-47fc-acd6-945ba954eb56 61 fields · synced Oct 5, 2026