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Integral dental unit
EUDAMEDClass IIa (EU MDR)
Ref ZC-S200Model ZC-S200, ZC-S300, ZC-S330, ZC-S430，ZC-E300, ZC-S400, ZC-S500, ZC-S730, ZC-S600, ZC-S700, ZC-S830, ZC-S800Ref ZC-A200
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-S200 EUDAMEDZC-A200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975643760014 EUDAMED
- Basic UDI-DI
- 697564376ZCXXXXA4 EUDAMEDB-06975643760014 EUDAMED
- Direct Marketing DI
- 06975643760014 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
Integral dental unit by Foshan Joinchamp Medical Device Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 21b156c0-9be8-47ed-b434-ceacadeb7076 61 fields · synced Jun 19, 2026
- EUDAMED 29a52c13-5863-49e2-b6c1-ee2b2dd7e24d 61 fields · synced Jun 19, 2026