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ApexFile sterile files
EUDAMEDClass IIa (EU MDR)
Ref ZAR2500030Model ZAR2500030 ApexFile sterile files 25mm Z30 (6 units)Ref ZAR21ASST1Model ZAR21ASST1 ApexFile sterile files 21mm Z25-Z40 (4 units)Ref ZAR3100040Model ZAR3100040 ApexFile sterile files 31mm Z40 (6 units)Ref ZAR31ASST1Model ZAR31ASST1 ApexFile sterile files 31mm Z25-Z40 (4 units)Ref ZAR2500035Model ZAR2500035 ApexFile sterile files 25mm Z35 (6 units)Ref ZAR3100030Model ZAR3100030 ApexFile sterile files 31mm Z30 (6 units)Ref ZAR2500025Model ZAR2500025 ApexFile sterile files 25mm Z25 (6 units)Ref ZAR2100040Model ZAR2100040 ApexFile sterile files 21mm Z40 (6 units)Ref ZAR2100035Model ZAR2100030 ApexFile sterile files 21mm Z30 (6 units)
Identity
- Trade Name
- ApexFile sterile files EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- ZAR2500030 ApexFile sterile files 25mm Z30 (6 units) EUDAMEDZAR2500030 EUDAMEDZAR21ASST1 ApexFile sterile files 21mm Z25-Z40 (4 units) EUDAMEDZAR21ASST1 EUDAMEDZAR3100040 ApexFile sterile files 31mm Z40 (6 units) EUDAMEDZAR3100040 EUDAMEDZAR31ASST1 ApexFile sterile files 31mm Z25-Z40 (4 units) EUDAMEDZAR31ASST1 EUDAMEDZAR2500035 ApexFile sterile files 25mm Z35 (6 units) EUDAMEDZAR2500035 EUDAMEDZAR3100030 ApexFile sterile files 31mm Z30 (6 units) EUDAMEDZAR3100030 EUDAMEDZAR2500025 ApexFile sterile files 25mm Z25 (6 units) EUDAMEDZAR2500025 EUDAMEDZAR2100040 ApexFile sterile files 21mm Z40 (6 units) EUDAMEDZAR2100040 EUDAMEDZAR2100030 ApexFile sterile files 21mm Z30 (6 units) EUDAMEDZAR2100035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512510254 EUDAMED06942512510230 EUDAMED06942512510049 EUDAMED06942512510056 EUDAMED06942512509982 EUDAMED06942512510025 EUDAMED06942512510247 EUDAMED06942512510223 EUDAMED06942512510209 EUDAMED
- Basic UDI-DI
- B-06942512510254 EUDAMEDB-06942512510230 EUDAMEDB-06942512510049 EUDAMEDB-06942512510056 EUDAMEDB-06942512509982 EUDAMEDB-06942512510025 EUDAMEDB-06942512510247 EUDAMEDB-06942512510223 EUDAMEDB-06942512510209 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
ApexFile sterile files 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-06942512510254 | 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 (9)
- EUDAMED 84697a8b-ea1f-4166-ae24-c005be58cb77 61 fields · synced Jul 26, 2026
- EUDAMED 908f75d9-9596-4302-a8b1-ded2c87788a6 61 fields · synced May 17, 2026
- EUDAMED 1c133cd6-b805-44a6-8768-91f3cfcab5b1 61 fields · synced May 17, 2026
- EUDAMED 947b86ca-5257-457f-8e8f-d5de7342cba1 61 fields · synced May 17, 2026
- EUDAMED 854c6a96-d7ac-4b9a-aaf2-61fbeb0ed7a2 61 fields · synced May 17, 2026
- EUDAMED 09e61fd1-dbfe-4e1d-bab5-c844a4b2fe83 61 fields · synced May 17, 2026
- EUDAMED 523ff248-e4f5-4622-a426-81ca02026df7 61 fields · synced May 18, 2026
- EUDAMED 8ff8e2a4-85e6-4837-9cc0-c0ad660ac1e4 61 fields · synced May 18, 2026
- EUDAMED b5250a18-7604-42f1-9289-f723fe2347ec 61 fields · synced May 18, 2026