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BlueShaper PRO
EUDAMEDClass IIa (EU MDR)
Ref ZBS19PROZXModel BlueShaper PRO sterile 19mm ZX
Identity
- Trade Name
- BlueShaper PRO EUDAMED
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- BlueShaper PRO sterile 19mm ZX EUDAMEDZBS19PROZX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718052037 EUDAMED
- Basic UDI-DI
- B-06975718052037 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-06975718052037 | 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 b2f7c487-2f9c-4c94-9ad1-4d51e6d33ec0 61 fields · synced Jun 19, 2026