Identity
- Trade Name
- Retainer and matrix M5 2.0 EUDAMED
- Device Name
- MATRIX BANDS EUDAMED
- Model / Reference
- DMB1211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971241393982 EUDAMED
- Basic UDI-DI
- 697124139DMB00019A EUDAMED
- EMDN Code
- Q019003 DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Retainer and matrix M5 2.0 by Tangshan Zhengtong Exhibition 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 | 697124139DMB00019A | Class I | Active |
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Manufacturer
- Manufacturer
- Tangshan Zhengtong Exhibition Co., Ltd.
- EUDAMED SRN
- CN-MF-000018452
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED a26da596-24f5-449f-9818-a9ed043e96c6 61 fields · synced Oct 6, 2026