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ApexFile Wide sterile files
EUDAMEDClass IIa (EU MDR)
Ref ZAW2500050Model ZAW2500050 ApexFile Wide sterile files 25mm Z50 (6 units)Ref ZAW3100035Model ZAW3100035 ApexFile Wide sterile files 31mm Z35 (6 units)Ref ZAW3100070Model ZAW3100070 ApexFile Wide sterile files 31mm Z70 (6 units)Ref ZAW2100070Model ZAW2100070 ApexFile Wide sterile files 21mm Z70 (6 units)Ref ZAW25ASST1Model ZAW25ASST1 ApexFile Wide sterile files 25mm Z35-Z70 (3 units)Ref ZAW2500070Model ZAW2500070 ApexFile Wide sterile files 25mm Z70 (6 units)Ref ZAW2100050Model ZAW2100050 ApexFile Wide sterile files 21mm Z50 (6 units)Ref ZAW2100035Model ZAW2100035 ApexFile Wide sterile files 21mm Z35 (6 units)
Identity
- Trade Name
- ApexFile Wide sterile files EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- ZAW2500050 ApexFile Wide sterile files 25mm Z50 (6 units) EUDAMEDZAW2500050 EUDAMEDZAW3100035 ApexFile Wide sterile files 31mm Z35 (6 units) EUDAMEDZAW3100035 EUDAMEDZAW3100070 ApexFile Wide sterile files 31mm Z70 (6 units) EUDAMEDZAW3100070 EUDAMEDZAW2100070 ApexFile Wide sterile files 21mm Z70 (6 units) EUDAMEDZAW2100070 EUDAMEDZAW25ASST1 ApexFile Wide sterile files 25mm Z35-Z70 (3 units) EUDAMEDZAW25ASST1 EUDAMEDZAW2500070 ApexFile Wide sterile files 25mm Z70 (6 units) EUDAMEDZAW2500070 EUDAMEDZAW2100050 ApexFile Wide sterile files 21mm Z50 (6 units) EUDAMEDZAW2100050 EUDAMEDZAW2100035 ApexFile Wide sterile files 21mm Z35 (6 units) EUDAMEDZAW2100035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512510117 EUDAMED06942512510148 EUDAMED06942512510162 EUDAMED06942512510087 EUDAMED06942512510131 EUDAMED06942512510124 EUDAMED06942512510070 EUDAMED06942512510063 EUDAMED
- Basic UDI-DI
- B-06942512510117 EUDAMEDB-06942512510148 EUDAMEDB-06942512510162 EUDAMEDB-06942512510087 EUDAMEDB-06942512510131 EUDAMEDB-06942512510124 EUDAMEDB-06942512510070 EUDAMEDB-06942512510063 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 Wide 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-06942512510117 | 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 (8)
- EUDAMED 20a9292b-25ec-495f-a280-cd092cd9458a 61 fields · synced Jul 29, 2026
- EUDAMED 4fb61ef8-d804-4d09-945e-f31b0ed3ebd0 61 fields · synced May 11, 2026
- EUDAMED 0c43a297-2c4e-433a-af57-2daf917e1258 61 fields · synced May 11, 2026
- EUDAMED 7b789e84-43e6-43f8-87bf-9cc163d19bc4 61 fields · synced May 16, 2026
- EUDAMED 245addde-c6a6-4c3d-ae70-e1ea187d0a3e 61 fields · synced May 17, 2026
- EUDAMED c31eb8a2-f2e8-46e6-966d-7a5b649b87a6 61 fields · synced May 17, 2026
- EUDAMED f22d913a-76e7-4d7f-9839-6305fae18505 61 fields · synced May 18, 2026
- EUDAMED f0d06aaa-beda-48cb-89f1-b956974ffd72 61 fields · synced May 18, 2026