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Limas BlueShaper de Zarc
EUDAMEDClass IIa (EU MDR)
Ref ZBS16000ZXModel Limas BlueShaper de Zarc (BlueShaper ZXS 16mm)
Identity
- Trade Name
- Limas BlueShaper de Zarc EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas BlueShaper de Zarc (BlueShaper ZXS 16mm) EUDAMEDZBS16000ZX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718056318 EUDAMED
- Basic UDI-DI
- B-06975718056318 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 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-06975718056318 | 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 4e6a8b58-7d9e-4729-b485-08939cf51627 61 fields · synced Jun 18, 2026