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BlueShaper PRO
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZBS31APRO4Model BlueShaper PRO sterile 31mm Z1-Z4Ref ZBS21ZPRO5Model BlueShaper PRO sterile 21mm Z5Ref ZBS31ZPRO5Model BlueShaper PRO sterile 31mm Z5Ref ZBS31ZPRO4Model BlueShaper PRO sterile 31mm Z4Ref ZBS21ZPRO6Model BlueShaper PRO sterile 21mm Z6Ref ZBS31ZPRO6Model BlueShaper PRO sterile 31mm Z6
Identity
- Trade Name
- BlueShaper PRO EUDAMEDZARC FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Dental Root Canal Instruments EUDAMED
- Model / Reference
- BlueShaper PRO sterile 31mm Z1-Z4 EUDAMEDZBS31APRO4 EUDAMEDBlueShaper PRO sterile 21mm Z5 EUDAMEDZBS21ZPRO5 EUDAMEDBlueShaper PRO sterile 31mm Z5 EUDAMEDZBS31ZPRO5 EUDAMEDBlueShaper PRO sterile 31mm Z4 EUDAMEDZBS31ZPRO4 EUDAMEDBlueShaper PRO sterile 21mm Z6 EUDAMEDZBS21ZPRO6 EUDAMEDBlueShaper PRO sterile 31mm Z6 EUDAMEDZBS31ZPRO6 EUDAMEDBlueShaper PRO sterile files 31mm Z1-Z4 (4 units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718052020 EUDAMEDFDA UDI06975718052099 EUDAMED06975718052259 EUDAMED06975718052242 EUDAMED06975718052105 EUDAMED06975718052266 EUDAMED
- Basic UDI-DI
- B-06975718052020 EUDAMEDB-06975718052099 EUDAMEDB-06975718052259 EUDAMEDB-06975718052242 EUDAMEDB-06975718052105 EUDAMEDB-06975718052266 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q030311 ENT SURGERY RASPS AND FILES, SINGLE-USE EUDAMED
- GMDN Term
- Manual endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
BlueShaper PRO by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975718052020 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (7)
- EUDAMED 3b562a39-58a6-4dd3-95c4-81b4ff190113 61 fields · synced Sep 18, 2026
- EUDAMED 17d9df6b-f245-475d-b76c-8fee8218aa4f 61 fields · synced May 17, 2026
- EUDAMED 48d79ec8-81d1-46ba-8a73-b27537f327b5 61 fields · synced May 17, 2026
- EUDAMED 6e174ff3-810f-47e6-b4e4-bebf051b52a1 61 fields · synced May 17, 2026
- EUDAMED 73f1231c-d28b-4cbc-8e2e-0cc64da41572 61 fields · synced May 17, 2026
- EUDAMED f1d9aa9b-b411-4cc3-a745-aa3de823d8c8 61 fields · synced May 18, 2026
- FDA UDI 6fb41358-1b30-43eb-aeb2-6939d591cb8d 33 fields · synced May 30, 2026