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Dental Root-canal Instruments
EUDAMEDClass IIa (EU MDR)
Ref AK2220408AModel Condensers
Identity
- Device Name
- Dental Root-canal Instruments EUDAMED
- Model / Reference
- Condensers EUDAMEDAK2220408A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944835191172 EUDAMED
- Basic UDI-DI
- B-06944835191172 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental Root-canal Instruments by Shenzhen Superline Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944835191172 | Class IIa | 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 687548e5-df6c-4c25-8124-50598d33e718 61 fields · synced Jun 19, 2026