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S.S Spiral Fillers
EUDAMEDClass IIa (EU MDR)
Ref CODE112135Model E11 S.S Spiral Fillers 4s 21mm No.35Ref CODE112125Model E11 S.S Spiral Fillers 4s 21mm No.25Ref CODE112140Model E11 S.S Spiral Fillers 4s 21mm No.40Ref CODE1125ASSTModel E11 S.S Spiral Fillers 4s 25mm Asst.Ref CODE112130Model E11 S.S Spiral Fillers 4s 21mm No.30
Identity
- Trade Name
- S.S Spiral Fillers EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E11 S.S Spiral Fillers 4s 21mm No.35 EUDAMEDCODE112135 EUDAMEDE11 S.S Spiral Fillers 4s 21mm No.25 EUDAMEDCODE112125 EUDAMEDE11 S.S Spiral Fillers 4s 21mm No.40 EUDAMEDCODE112140 EUDAMEDE11 S.S Spiral Fillers 4s 25mm Asst. EUDAMEDCODE1125ASST EUDAMEDE11 S.S Spiral Fillers 4s 21mm No.30 EUDAMEDCODE112130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512504000 EUDAMED06942512503980 EUDAMED06942512504017 EUDAMED06942512504079 EUDAMED06942512503997 EUDAMED
- Basic UDI-DI
- B-06942512504000 EUDAMEDB-06942512503980 EUDAMEDB-06942512504017 EUDAMEDB-06942512504079 EUDAMEDB-06942512503997 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
S.S Spiral Fillers by Shenzhen Denco Medical 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-06942512504000 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (5)
- EUDAMED 1984a2fe-d229-4556-816f-63d0b414d981 61 fields · synced Jul 30, 2026
- EUDAMED 222349af-fbf1-4100-8aaf-76c2f589617f 61 fields · synced May 16, 2026
- EUDAMED 83ebb629-97c9-42cc-9701-388c8f6c5439 61 fields · synced May 17, 2026
- EUDAMED efc3231a-f1b4-44f0-90d9-38ad955aebdb 61 fields · synced May 17, 2026
- EUDAMED 9858763a-a9d3-44dd-b233-bd76603a9e7e 61 fields · synced May 17, 2026