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Dental Root Canal Instruments
EUDAMEDClass IIa (EU MDR)
Ref T1.00/NITI/K/15#-40#-assorted/21mm/h/6pcModel Dental Root Canal Instruments
Identity
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Dental Root Canal Instruments EUDAMEDT1.00/NITI/K/15#-40#-assorted/21mm/h/6pc EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977854444349 EUDAMED
- Basic UDI-DI
- 697492240FILESMT EUDAMED
- EMDN Code
- Q010508 DENTAL SURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 Root Canal Instruments by Shanghai Xingyu Medical Equipment Co., Ltd — Class IIa — 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 | 697492240FILESMT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Xingyu Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000032268
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 24781f9e-02c7-48f2-b841-19b5a9fc2735 61 fields · synced Jun 18, 2026