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Twist One Gold
EUDAMEDClass IIa (EU MDR)
Ref TWONE.21.020Model TWONE.21.020 Twist One Gold 21mm Small#020/07Ref TWONE.31.045Model TWONE.31.045 Twist One Gold 31mm Large#045/05Ref TWONE.31.035Model TWONE.31.035 Twist One Gold 31mm Medium#035/06Ref TWONE.25.045Model TWONE.25.045 Twist One Gold 25mm Large#045/05Ref TWONE.25.020Model TWONE.25.020 Twist One Gold 25mm Small#020/07Ref TWONE.25.SETModel TWONE.25.SET Twist One Gold 25mm Small#020/07,Primary#025/07,Medium#035/06,Large#045/05Ref TWONE.31.020Model TWONE.31.020 Twist One Gold 31mm Small#020/07Ref TWONE.25.035Model TWONE.25.035 Twist One Gold 25mm Medium#035/06
Identity
- Trade Name
- Twist One Gold EUDAMED
- Device Name
- Twist One Gold EUDAMED
- Model / Reference
- TWONE.21.020 Twist One Gold 21mm Small#020/07 EUDAMEDTWONE.21.020 EUDAMEDTWONE.31.045 Twist One Gold 31mm Large#045/05 EUDAMEDTWONE.31.045 EUDAMEDTWONE.31.035 Twist One Gold 31mm Medium#035/06 EUDAMEDTWONE.31.035 EUDAMEDTWONE.25.045 Twist One Gold 25mm Large#045/05 EUDAMEDTWONE.25.045 EUDAMEDTWONE.25.020 Twist One Gold 25mm Small#020/07 EUDAMEDTWONE.25.020 EUDAMEDTWONE.25.SET Twist One Gold 25mm Small#020/07,Primary#025/07,Medium#035/06,Large#045/05 EUDAMEDTWONE.25.SET EUDAMEDTWONE.31.020 Twist One Gold 31mm Small#020/07 EUDAMEDTWONE.31.020 EUDAMEDTWONE.25.035 Twist One Gold 25mm Medium#035/06 EUDAMEDTWONE.25.035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512512289 EUDAMED06942512512401 EUDAMED06942512512425 EUDAMED06942512512340 EUDAMED06942512512333 EUDAMED06942512512357 EUDAMED06942512512388 EUDAMED06942512512371 EUDAMED
- Basic UDI-DI
- B-06942512512289 EUDAMEDB-06942512512401 EUDAMEDB-06942512512425 EUDAMEDB-06942512512340 EUDAMEDB-06942512512333 EUDAMEDB-06942512512357 EUDAMEDB-06942512512388 EUDAMEDB-06942512512371 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
Twist One Gold 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-06942512512289 | 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 c1451101-3aa0-4719-b48e-8785ffdf9db8 61 fields · synced Aug 1, 2026
- EUDAMED 30b0550d-d755-470a-9963-ea0cc6cc46c8 61 fields · synced May 16, 2026
- EUDAMED 8b462415-a841-449d-b615-8cf051e426fe 61 fields · synced May 17, 2026
- EUDAMED 013883b8-7677-4f97-a611-ffcf8ea04dca 61 fields · synced May 17, 2026
- EUDAMED d75ac6fd-79d8-423d-8033-d9140e5c529d 61 fields · synced May 17, 2026
- EUDAMED cee4d388-aa7e-42e1-97b0-fbb6a4ca7625 61 fields · synced May 18, 2026
- EUDAMED eadcb70b-c991-4c69-b284-3040d7730b66 61 fields · synced May 18, 2026
- EUDAMED ba6a9856-2894-413f-8ac6-3de151cb11ad 61 fields · synced May 18, 2026