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root canal files
EUDAMEDClass I (EU MDR)
Ref 250405Model 250401/250402/250403/250404/250405/250406/250407/250408/250409/250410/250411/250412/250413/250414/250415/250416/250417/250418/250419/250420
Identity
- Device Name
- root canal files EUDAMED
- Model / Reference
- 250401/250402/250403/250404/250405/250406/250407/250408/250409/250410/250411/250412/250413/250414/250415/250416/250417/250418/250419/250420 EUDAMED250405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429778302 EUDAMED
- Basic UDI-DI
- 697842977ZWRCF7Q EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE 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
root canal files by Across Industrial 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 | 697842977ZWRCF7Q | Class I | Active |
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Manufacturer
- Manufacturer
- Across Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000047003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 66d5d854-6602-4e79-a637-9dcdad59b838 61 fields · synced Jun 18, 2026