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Z-Micro Opener
EUDAMEDClass IIa (EU MDR)
Ref ZMOAModel Z-Micro Opener ASSORTED (3 units)Ref ZMO3Model Z-Micro Opener de Zarc (Calibre 20 .04) (3 units)
Identity
- Trade Name
- Z-Micro Opener EUDAMED
- Device Name
- Z-Micro Opener EUDAMED
- Model / Reference
- Z-Micro Opener ASSORTED (3 units) EUDAMEDZMOA EUDAMEDZ-Micro Opener de Zarc (Calibre 20 .04) (3 units) EUDAMEDZMO3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718057629 EUDAMED06975718057612 EUDAMED
- Basic UDI-DI
- B-06975718057629 EUDAMEDB-06975718057612 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
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
Z-Micro Opener 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-06975718057629 | 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 (2)
- EUDAMED 9fca967c-5439-46f6-8f07-60de471714fc 61 fields · synced Aug 3, 2026
- EUDAMED a626e0d3-9d7a-479a-ab1c-c4f4e24a46f2 61 fields · synced May 19, 2026