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root canal files
EUDAMEDClass I (EU MDR)
Ref 250402Model 250401/250402/250403/250404/250405/250406/250407/250408/250409/250410/250411/250412/250413/250414/250415/250416/250417/250418/250419/250420Ref 250407Ref 250418Ref 250408Ref 250404Ref 250415Ref 250413Ref 250416Ref 250410Ref 250401Ref 250411Ref 250419Ref 250412
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 EUDAMED250402 EUDAMED250407 EUDAMED250418 EUDAMED250408 EUDAMED250404 EUDAMED250415 EUDAMED250413 EUDAMED250416 EUDAMED250410 EUDAMED250401 EUDAMED250411 EUDAMED250419 EUDAMED250412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978429778272 EUDAMED06978429778326 EUDAMED06978429778432 EUDAMED06978429778333 EUDAMED06978429778296 EUDAMED06978429778401 EUDAMED06978429778388 EUDAMED06978429778418 EUDAMED06978429778357 EUDAMED06978429778265 EUDAMED06978429778364 EUDAMED06978429778449 EUDAMED06978429778371 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 (13)
- EUDAMED d21cc652-7728-4172-9dbe-96ad4c707fc5 61 fields · synced Oct 5, 2026
- EUDAMED 1acd4274-7fb3-4541-bcf0-263c37951b61 61 fields · synced May 11, 2026
- EUDAMED 4304d98f-4d54-4742-95ca-1d270f270dea 61 fields · synced May 16, 2026
- EUDAMED 38ec02af-ed0d-4487-9e3c-64b5597861e1 61 fields · synced May 16, 2026
- EUDAMED a0e246ae-45b6-4eb6-9354-9dbdf2d5f605 61 fields · synced May 16, 2026
- EUDAMED d0247038-d6c2-42e7-bc55-c5456952ad50 61 fields · synced May 16, 2026
- EUDAMED a7a1a022-18ac-420e-9aeb-fa27861489a7 61 fields · synced May 17, 2026
- EUDAMED 42ebf80f-8d03-4703-9ca9-1d73cf627ac4 61 fields · synced May 17, 2026
- EUDAMED c96c79f6-64ae-4e6c-82e3-2f5dfa21410a 61 fields · synced May 17, 2026
- EUDAMED 1dc36f05-1e67-4363-a4ab-657c28d38319 61 fields · synced May 18, 2026
- EUDAMED 783348e7-4a98-4dea-9b16-7ab4c9ff5941 61 fields · synced May 18, 2026
- EUDAMED 0d9ba619-4733-4b17-8065-74bde7a8c62a 61 fields · synced May 18, 2026
- EUDAMED ab9f640a-b1e7-4724-9c79-d850ca7f595f 61 fields · synced May 18, 2026