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Twist One Gold
EUDAMEDClass IIa (EU MDR)
Ref TWONE.21.035Model TWONE.21.035 Twist One Gold 21mm Medium#035/06
Identity
- Trade Name
- Twist One Gold EUDAMED
- Device Name
- Twist One Gold EUDAMED
- Model / Reference
- TWONE.21.035 Twist One Gold 21mm Medium#035/06 EUDAMEDTWONE.21.035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512512302 EUDAMED
- Basic UDI-DI
- B-06942512512302 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-06942512512302 | 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 ac6fb067-c928-4b74-ba93-7b268e2f47ce 61 fields · synced Jun 19, 2026