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Blue-Ace.rezi
EUDAMEDClass IIa (EU MDR)
Ref ACE.25.40Model ACE.25.40 BLUE-ACE.REZI 25mm #40Ref ACE.21.50Model ACE.21.50 BLUE-ACE.REZI 21mm #50Ref ACE.25.50Model ACE.25.50 BLUE-ACE.REZI 25mm #50Ref ACE.31.ASSModel ACE.31.ASS BLUE-ACE.REZI 31mm C+10#,#25,#40,#50Ref ACE.31.40Model ACE.31.40 BLUE-ACE.REZI 31mm #40Ref ACE.25.25Model ACE.25.25 BLUE-ACE.REZI 25mm #25
Identity
- Trade Name
- BLUE-ACE.REZI EUDAMED
- Device Name
- BLUE-ACE.REZI EUDAMED
- Model / Reference
- ACE.25.40 BLUE-ACE.REZI 25mm #40 EUDAMEDACE.25.40 EUDAMEDACE.21.50 BLUE-ACE.REZI 21mm #50 EUDAMEDACE.21.50 EUDAMEDACE.25.50 BLUE-ACE.REZI 25mm #50 EUDAMEDACE.25.50 EUDAMEDACE.31.ASS BLUE-ACE.REZI 31mm C+10#,#25,#40,#50 EUDAMEDACE.31.ASS EUDAMEDACE.31.40 BLUE-ACE.REZI 31mm #40 EUDAMEDACE.31.40 EUDAMEDACE.25.25 BLUE-ACE.REZI 25mm #25 EUDAMEDACE.25.25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718057995 EUDAMED06975718057971 EUDAMED06975718057728 EUDAMED06975718058022 EUDAMED06975718058008 EUDAMED06975718057711 EUDAMED
- Basic UDI-DI
- B-06975718057995 EUDAMEDB-06975718057971 EUDAMEDB-06975718057728 EUDAMEDB-06975718058022 EUDAMEDB-06975718058008 EUDAMEDB-06975718057711 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Blue-Ace.rezi 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-06975718057995 | 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 (6)
- EUDAMED 005a23d2-4a9d-4c20-ab22-421cffe015b3 61 fields · synced Jul 26, 2026
- EUDAMED dcf4a181-cded-4649-b68e-3e03bbc5878a 61 fields · synced May 17, 2026
- EUDAMED 54653386-d7a7-4510-8c1e-5e2fe5996f9e 61 fields · synced May 18, 2026
- EUDAMED 0ce17025-a795-4150-b56b-2fe9c175b65f 61 fields · synced May 18, 2026
- EUDAMED 938f51c2-a9a4-4dfe-81b6-7b4b076461be 61 fields · synced May 18, 2026
- EUDAMED a9df9f8a-0edb-4550-8093-70d32113459b 61 fields · synced May 18, 2026