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ApicalShaper sterile files
EUDAMEDClass IIa (EU MDR)
Ref ZAS3104003Model ApicalShaper sterile files 31mm Z40/03 (6 units)
Identity
- Trade Name
- ApicalShaper sterile files EUDAMED
- Model / Reference
- ApicalShaper sterile files 31mm Z40/03 (6 units) EUDAMEDZAS3104003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718050668 EUDAMED
- Basic UDI-DI
- B-06975718050668 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
ApicalShaper 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-06975718050668 | 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 (1)
- EUDAMED b2a9a75d-188c-493a-9bd5-3f074120fc54 61 fields · synced Jun 19, 2026