Identity
- Trade Name
- Root Canal Files EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- K, H, Reamers, C EUDAMEDBA1030400A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944835158816 EUDAMED
- Basic UDI-DI
- 69448351ENDO01NS2X EUDAMED
- Direct Marketing DI
- 06944835158816 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
Root Canal Files by Shenzhen Superline Technology 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 | 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 0bc764ea-5365-4038-ba58-0410ca73ef73 61 fields · synced Jun 17, 2026