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BlueShaper PRO
EUDAMEDClass IIa (EU MDR)
Ref ZBS21APRO6Model BlueShaper PRO sterile 21mm ZX-Z5
Identity
- Trade Name
- BlueShaper PRO EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- BlueShaper PRO sterile 21mm ZX-Z5 EUDAMEDZBS21APRO6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718052044 EUDAMED
- Basic UDI-DI
- B-06975718052044 EUDAMED
- EMDN Code
- Q030311 ENT SURGERY RASPS AND FILES, 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 PRO 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-06975718052044 | 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 df4ca4e9-b9c3-4a6f-959b-906f3f6a33ec 61 fields · synced Jun 17, 2026