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File Organizer and autoclavable ruler
EUDAMEDClass IIa (EU MDR)
Ref ZSTANDYModel File Organizer and autoclavable ruler - ZARC Yellow
Identity
- Trade Name
- File Organizer and autoclavable ruler EUDAMED
- Model / Reference
- File Organizer and autoclavable ruler - ZARC Yellow EUDAMEDZSTANDY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718051917 EUDAMED
- Basic UDI-DI
- B-06975718051917 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
File Organizer and autoclavable ruler 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-06975718051917 | 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 95dc96c3-335c-43e3-a04c-2f3ec58ac853 61 fields · synced Jun 18, 2026