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Dental Sectional Contoured Matrices Kits
EUDAMEDClass I (EU MDR)
Ref SC1804Model SC01,SC1001,SC1101,SC0103,SC0104, SC1002,SC1102,SC15,SC1502,SC1503, SC1801,SC1802,SC1803,SC1804
Identity
- Trade Name
- Dental Sectional Contoured Matrices Kits EUDAMED
- Device Name
- Dental Sectional Contoured Matrices Kits EUDAMED
- Model / Reference
- SC01,SC1001,SC1101,SC0103,SC0104, SC1002,SC1102,SC15,SC1502,SC1503, SC1801,SC1802,SC1803,SC1804 EUDAMEDSC1804 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454011737 EUDAMED
- Basic UDI-DI
- 69544540DSCM001PC EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dental Sectional Contoured Matrices Kits by Huanghua Promisee Dental 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 | 69544540DSCM001PC | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4323ed51-344e-4da0-9cf5-95873a1f2821 61 fields · synced Jun 18, 2026