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Limas BlueShaper
EUDAMEDClass IIa (EU MDR)
Ref ZBS21ASST4Model Limas BlueShaper estériles 21mm Z1-Z4 (4 uds.)Ref ZBS21Z0005Model Limas BlueShaper estériles 21mm Z5 (6 uds.)Ref ZBS25Z0007Model Limas BlueShaper estériles 25mm Z7 (6 uds.)Ref ZBS31ASST6Model Limas BlueShaper estériles 31mm ZX-Z5 (6 uds.)
Identity
- Trade Name
- Limas BlueShaper EUDAMEDLimas BlueShaper estériles 21mm Z5 (6 uds.) EUDAMEDLimas BlueShaper estériles EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- Limas BlueShaper estériles 21mm Z1-Z4 (4 uds.) EUDAMEDZBS21ASST4 EUDAMEDLimas BlueShaper estériles 21mm Z5 (6 uds.) EUDAMEDZBS21Z0005 EUDAMEDLimas BlueShaper estériles 25mm Z7 (6 uds.) EUDAMEDZBS25Z0007 EUDAMEDLimas BlueShaper estériles 31mm ZX-Z5 (6 uds.) EUDAMEDZBS31ASST6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718050019 EUDAMED06975718050101 EUDAMED06975718050200 EUDAMED06975718050217 EUDAMED
- Basic UDI-DI
- B-06975718050019 EUDAMEDB-06975718050101 EUDAMEDB-06975718050200 EUDAMEDB-06975718050217 EUDAMED
- EMDN Code
- Q030311 ENT SURGERY RASPS AND FILES, SINGLE-USE EUDAMEDQ010507 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 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-06975718050019 | 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 (4)
- EUDAMED 95a60d31-461d-42d8-ba47-54e0ca39d85c 61 fields · synced Jul 31, 2026
- EUDAMED d76b8e9b-d4d7-45fc-8a3c-0370b5d80870 61 fields · synced May 17, 2026
- EUDAMED bd697254-cb74-430b-8d52-7fe2e01b9e54 61 fields · synced May 18, 2026
- EUDAMED 4636111b-53ed-4b9c-a94d-ce631b242ecb 61 fields · synced May 18, 2026