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Integral dental unit
EUDAMEDClass IIa (EU MDR)
Ref CX-8000Ref DTC-326Ref CX-8900Ref DTC-327Ref DTC-328Ref CX-9000
Identity
- Trade Name
- Integral dental unit EUDAMED
- Device Name
- Integral dental unit EUDAMED
- Model / Reference
- CX-8000 EUDAMEDDTC-326 EUDAMEDCX-8900 EUDAMEDDTC-327 EUDAMEDDTC-328 EUDAMEDCX-9000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975582138004 EUDAMED06975582133269 EUDAMED06975582138905 EUDAMED06975582133276 EUDAMED06975582133283 EUDAMED06975582139001 EUDAMED
- Basic UDI-DI
- B-06975582138004 EUDAMEDB-06975582133269 EUDAMEDB-06975582138905 EUDAMEDB-06975582133276 EUDAMEDB-06975582133283 EUDAMEDB-06975582139001 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMEDLatvia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental delivery system
Integral dental unit by Foshan Chuangxin Medical Apparatus Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975582138004 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Chuangxin Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000011665
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 704595f9-a6ba-4710-96a1-13d5638974e9 61 fields · synced Aug 1, 2026
- EUDAMED e4de10de-4be2-4846-a060-6957a188bab0 61 fields · synced May 17, 2026
- EUDAMED 6308715b-b81e-4fab-a633-54034ed03453 61 fields · synced May 18, 2026
- EUDAMED 964a721a-d2eb-40a5-964b-3ca8292fb5fb 61 fields · synced May 18, 2026
- EUDAMED 04a82d94-6629-475c-90fb-7ca7c9cbd1cb 61 fields · synced May 18, 2026
- EUDAMED 0d0bfc70-c8c1-4634-8b0b-4cc1a4406a55 61 fields · synced May 19, 2026