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Z-Micro Opener
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZMO2Model Z-Micro Opener de Zarc (Calibre 15 .04) (3 units)
Identity
- Trade Name
- Z-Micro Opener EUDAMEDZARC FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Z-Micro Opener EUDAMED
- Model / Reference
- Z-Micro Opener de Zarc (Calibre 15 .04) (3 units) EUDAMEDZMO2 EUDAMEDZ-Micro Opener de Zarc (Calibre 15 .04) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718057650 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06975718057650 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Manual endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Z-Micro Opener by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975718057650 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 adbe7495-f574-4848-9385-9d73a605df46 61 fields · synced Jul 13, 2026
- FDA UDI 35666f1c-45de-4a9b-93c7-0eb64a145135 33 fields · synced May 29, 2026