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BlueShaper sterile files
EUDAMEDClass IIa (EU MDR)
Ref ZBS21Z0007Model BlueShaper sterile files 21mm Z7 (6 units)Ref ZBS21Z0006Model BlueShaper sterile files 21mm Z6 (6 units)Ref ZBS31Z0007Model BlueShaper sterile files 31mm Z7 (6 units)
Identity
- Trade Name
- BlueShaper sterile files EUDAMED
- Model / Reference
- BlueShaper sterile files 21mm Z7 (6 units) EUDAMEDZBS21Z0007 EUDAMEDBlueShaper sterile files 21mm Z6 (6 units) EUDAMEDZBS21Z0006 EUDAMEDBlueShaper sterile files 31mm Z7 (6 units) EUDAMEDZBS31Z0007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718050125 EUDAMED06975718050118 EUDAMED06975718050286 EUDAMED
- Basic UDI-DI
- B-06975718050125 EUDAMEDB-06975718050118 EUDAMEDB-06975718050286 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
BlueShaper sterile files 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-06975718050125 | 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 (3)
- EUDAMED f9e2674f-5322-4fd9-9501-e43c5fc7fba0 61 fields · synced Jul 29, 2026
- EUDAMED 298869bb-9017-4c8c-a7e5-a379ba1d99d9 61 fields · synced May 18, 2026
- EUDAMED 273989d3-c301-427a-b37b-2908d8ae95a7 61 fields · synced May 18, 2026