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Cx100-B1
EUDAMEDClass I (EU MDR)
Ref 0967Model CX100-A1, CX100-A2, CX100-B1,CX100-BL
Identity
- Trade Name
- CX100-B1 EUDAMED
- Device Name
- Try-In Resin EUDAMED
- Model / Reference
- CX100-A1, CX100-A2, CX100-B1,CX100-BL EUDAMED0967 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975338700967 EUDAMED
- Basic UDI-DI
- 697533870CX100HE EUDAMED
- Direct Marketing DI
- 06975338700967 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Cx100-B1 by Hangzhou SHINING3D Dental Technology Co., Ltd. — Class I — 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 | 697533870CX100HE | Class I | 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 d18957f6-7a2c-4b24-a4b9-b1f15ae3602d 61 fields · synced Oct 6, 2026