Identity
- Trade Name
- Root Canal Files EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- K, H, Reamers EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944835190717 EUDAMED
- Basic UDI-DI
- 69448351ENDO02NS34 EUDAMED
- Direct Marketing DI
- 06944835190717 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Manual endodontic file/rasp, reusable
Root Canal Files by Shenzhen Superline Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
- K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
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- ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
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 | 69448351ENDO02NS34 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Superline Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027059
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 0250be36-55d4-4d45-8d26-f65ba47a97e4 61 fields · synced Jul 22, 2026
- EUDAMED 0250be36-55d4-4d45-8d26-f65ba47a97e4-1 61 fields · synced Jun 9, 2026