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Resin Matrix Bands
EUDAMEDClass I (EU MDR)
Ref /Model SC09,SC0601L,SC0602S,SC0501L,SC0502M,SC0503S,SC1201L,SC1202M,SC1203S,SC1301L,SC1302M,SC1303S,SC0504L,SC0505M,SC0506S,SC1204L,SC1205M,SC1206S,SC1304L,SC1305M,SC1306S,SC14L,SC14M,SC14S,QI18
Identity
- Trade Name
- Resin Matrix Bands EUDAMED
- Device Name
- Matrix Bands EUDAMED
- Model / Reference
- SC09,SC0601L,SC0602S,SC0501L,SC0502M,SC0503S,SC1201L,SC1202M,SC1203S,SC1301L,SC1302M,SC1303S,SC0504L,SC0505M,SC0506S,SC1204L,SC1205M,SC1206S,SC1304L,SC1305M,SC1306S,SC14L,SC14M,SC14S,QI18 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454002216 EUDAMED
- Basic UDI-DI
- 69544540MABO001LW EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Resin Matrix Bands 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 | 69544540MABO001LW | 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 ce65e6de-dcb5-424c-a9b0-6db78e0268ba 61 fields · synced Jun 19, 2026