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Integral dental unit
EUDAMEDClass IIa (EU MDR)
Ref ZC-S500Model ZC-S200, ZC-S300, ZC-S330, ZC-S430，ZC-E300, ZC-S400, ZC-S500, ZC-S730, ZC-S600, ZC-S700, ZC-S830, ZC-S800
Identity
- Trade Name
- Integral dental unit EUDAMED
- Device Name
- Integral dental unit EUDAMED
- Model / Reference
- ZC-S200, ZC-S300, ZC-S330, ZC-S430，ZC-E300, ZC-S400, ZC-S500, ZC-S730, ZC-S600, ZC-S700, ZC-S830, ZC-S800 EUDAMEDZC-S500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975643760076 EUDAMED
- Basic UDI-DI
- 697564376ZCXXXXA4 EUDAMEDB-06975643760076 EUDAMED
- Direct Marketing DI
- 06975643760076 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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 delivery system
Integral dental unit by Foshan Joinchamp Medical Device Co., Ltd. — Class IIa — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697564376ZCXXXXA4 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697564376ZCXXXXA4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Joinchamp Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000035680
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f33752c2-ebe9-42f6-b026-71cafaeca016 61 fields · synced Jul 10, 2026
- EUDAMED 581323db-0d7c-4cad-a17e-57710a74dbd2 61 fields · synced Jun 14, 2026