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Limas BlueShaper PRO de Zarc
EUDAMEDClass IIa (EU MDR)
Ref ZBS31APROSModel Limas BlueShaper PRO de Zarc (BlueShaper PRO surtidas ZXS-Z5 (6 unds.)31mm) 1.200,00 Unidades
Identity
- Trade Name
- Limas BlueShaper PRO de Zarc EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas BlueShaper PRO de Zarc (BlueShaper PRO surtidas ZXS-Z5 (6 unds.)31mm) 1.200,00 Unidades EUDAMEDZBS31APROS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718056356 EUDAMED
- Basic UDI-DI
- B-06975718056356 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
Limas BlueShaper PRO de Zarc 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-06975718056356 | 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 c044f825-ad2c-4259-8fae-181b77b86506 61 fields · synced Jun 17, 2026