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Ace.rezi
EUDAMEDClass IIa (EU MDR)
Ref ACE.S21.ASSModel ACE.S21.ASS ACE.REZI 21mm C+10#,#25,#40,#50Ref ACE.S25.40Model ACE.S25.40 ACE.REZI 25mm #40Ref ACE.S21.50Model ACE.S21.50 ACE.REZI 21mm #50Ref ACE.S31.50Model ACE.S31.50 ACE.REZI 31mm #50Ref ACE.S31.ASSModel ACE.S31.ASS ACE.REZI 31mm C+10#,#25,#40,#50Ref ACE.S21.25Model ACE.S21.25 ACE.REZI 21mm #25Ref ACE.S25.25Model ACE.S25.25 ACE.REZI 25mm #25Ref ACE.S21.40Model ACE.S21.40 ACE.REZI 21mm #40
Identity
- Trade Name
- ACE.REZI EUDAMED
- Device Name
- ACE.REZI EUDAMED
- Model / Reference
- ACE.S21.ASS ACE.REZI 21mm C+10#,#25,#40,#50 EUDAMEDACE.S21.ASS EUDAMEDACE.S25.40 ACE.REZI 25mm #40 EUDAMEDACE.S25.40 EUDAMEDACE.S21.50 ACE.REZI 21mm #50 EUDAMEDACE.S21.50 EUDAMEDACE.S31.50 ACE.REZI 31mm #50 EUDAMEDACE.S31.50 EUDAMEDACE.S31.ASS ACE.REZI 31mm C+10#,#25,#40,#50 EUDAMEDACE.S31.ASS EUDAMEDACE.S21.25 ACE.REZI 21mm #25 EUDAMEDACE.S21.25 EUDAMEDACE.S25.25 ACE.REZI 25mm #25 EUDAMEDACE.S25.25 EUDAMEDACE.S21.40 ACE.REZI 21mm #40 EUDAMEDACE.S21.40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718058060 EUDAMED06975718058084 EUDAMED06975718058053 EUDAMED06975718058138 EUDAMED06975718058145 EUDAMED06975718058039 EUDAMED06975718058077 EUDAMED06975718058046 EUDAMED
- Basic UDI-DI
- B-06975718058060 EUDAMEDB-06975718058084 EUDAMEDB-06975718058053 EUDAMEDB-06975718058138 EUDAMEDB-06975718058145 EUDAMEDB-06975718058039 EUDAMEDB-06975718058077 EUDAMEDB-06975718058046 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
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-06975718058060 | 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 (8)
- EUDAMED 56e946c4-19e9-41ef-bf98-10556d1ef3f6 61 fields · synced Sep 30, 2026
- EUDAMED 2802b4e9-aef1-464d-a5ec-7cfc2de429a7 61 fields · synced May 16, 2026
- EUDAMED adffcc0e-bbdc-4ccf-a7fc-5564fbb8e574 61 fields · synced May 16, 2026
- EUDAMED c1698b50-f031-48f7-b8e7-b0b072c595cb 61 fields · synced May 17, 2026
- EUDAMED 2099cbed-0526-477c-8e50-35567443e051 61 fields · synced May 18, 2026
- EUDAMED 3f5fdc49-04b7-47c9-87e4-483e889f8667 61 fields · synced May 18, 2026
- EUDAMED a6cdac35-5a7c-4ae9-9811-3cc6d0a94552 61 fields · synced May 18, 2026
- EUDAMED adef3e11-37f5-4169-9857-5b4ca6d0d0a7 61 fields · synced May 18, 2026