Identity
- Trade Name
- Root Canal Files EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- K, H, Reamers, C EUDAMEDBA1010406D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944835157451 EUDAMED
- Basic UDI-DI
- 69448351ENDO01NS2X EUDAMED
- Direct Marketing DI
- 06944835157451 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
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Also classified as Manual endodontic file/rasp, reusable.
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- 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 | 69448351ENDO01NS2X | 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 (1)
- EUDAMED 3e091c2f-553b-4a38-a086-ff7b3643cfb9 61 fields · synced Jun 18, 2026