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Z Condensor files
EUDAMEDClass IIa (EU MDR)
Ref ZCON03521Model Z Condensor files 21mm 035 (4 units)Ref ZCON04525Model Z Condensor files 25mm 045 (4 units)Ref ZCON03021Model Z-Condensor 21 mm 030 (4 uds.)Ref ZCON03525Model Z Condensor files 25mm 035 (4 units)Ref ZCON04025Model Z Condensor files 25mm 040 (4 units)Ref ZCON04021Model Z Condensor files 21mm 040 (4 units)
Identity
- Trade Name
- Z Condensor files EUDAMEDZ-Condensor EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Z Condensor files 21mm 035 (4 units) EUDAMEDZCON03521 EUDAMEDZ Condensor files 25mm 045 (4 units) EUDAMEDZCON04525 EUDAMEDZ-Condensor 21 mm 030 (4 uds.) EUDAMEDZCON03021 EUDAMEDZ Condensor files 25mm 035 (4 units) EUDAMEDZCON03525 EUDAMEDZ Condensor files 25mm 040 (4 units) EUDAMEDZCON04025 EUDAMEDZ Condensor files 21mm 040 (4 units) EUDAMEDZCON04021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718050781 EUDAMED06975718050859 EUDAMED06975718050774 EUDAMED06975718050835 EUDAMED06975718050842 EUDAMED06975718050798 EUDAMED
- Basic UDI-DI
- B-06975718050781 EUDAMEDB-06975718050859 EUDAMEDB-06975718050774 EUDAMEDB-06975718050835 EUDAMEDB-06975718050842 EUDAMEDB-06975718050798 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
Z Condensor 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-06975718050781 | 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 (6)
- EUDAMED 0c6ea47b-f8a1-40d1-a2a3-b39fa771913c 61 fields · synced Aug 2, 2026
- EUDAMED ed44b82c-b835-4115-971b-6805b742933b 61 fields · synced May 18, 2026
- EUDAMED 6d21afcc-7ce1-4bf6-af96-4bd7f4a7b135 61 fields · synced May 18, 2026
- EUDAMED 849a5e3e-badb-48da-8608-9c1c9fb40d94 61 fields · synced May 18, 2026
- EUDAMED 752223b2-447b-48a8-b880-c50b410a987f 61 fields · synced May 19, 2026
- EUDAMED c53f7aba-6e82-4248-9448-f21a52e9aaaf 61 fields · synced May 19, 2026