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Dual Shaper
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.25-025-VT-016-GD-000-00-00Model Dual Shaper 25mm #016 5pcs/blisterRef D-P.01.25-025-06-025-GD-000-00-00Model Dual Shaper 25mm #25/06 5pcs/blisterRef D-P.01.25-021-VT-0A0-RB-000-00-00Model Chameleon Series-Dual Shaper 21mm SX,#016,#20/04,#25/04,#25/06 5pcs/blisterRef D-P.01.25-025-04-025-GD-000-00-00Model Dual Shaper 25mm #25/04 5pcs/blisterRef D-P.01.25-021-06-025-RB-000-00-00Model Chameleon Series-Dual Shaper 21mm #25/06 5pcs/blisterRef D-P.01.25-021-04-025-RB-000-00-00Model Chameleon Series-Dual Shaper 21mm #25/04 5pcs/blisterRef D-P.01.25-025-04-020-RB-000-00-00Model Chameleon Series-Dual Shaper 25mm #20/04 5pcs/blisterRef D-P.01.25-025-04-020-GD-000-00-00Model Dual Shaper 25mm #20/04 5pcs/blisterRef D-P.01.25-025-04-025-RB-000-00-00Model Chameleon Series-Dual Shaper 25mm #25/04 5pcs/blisterRef D-P.01.25-025-VT-0A0-RB-000-00-00Model Chameleon Series-Dual Shaper 25mm SX,#016,#20/04,#25/04,#25/06 5pcs/blister
Identity
- Trade Name
- Dual Shaper EUDAMED
- Device Name
- Dual Shaper EUDAMED
- Model / Reference
- Dual Shaper 25mm #016 5pcs/blister EUDAMEDD-P.01.25-025-VT-016-GD-000-00-00 EUDAMEDDual Shaper 25mm #25/06 5pcs/blister EUDAMEDD-P.01.25-025-06-025-GD-000-00-00 EUDAMEDChameleon Series-Dual Shaper 21mm SX,#016,#20/04,#25/04,#25/06 5pcs/blister EUDAMEDD-P.01.25-021-VT-0A0-RB-000-00-00 EUDAMEDDual Shaper 25mm #25/04 5pcs/blister EUDAMEDD-P.01.25-025-04-025-GD-000-00-00 EUDAMEDChameleon Series-Dual Shaper 21mm #25/06 5pcs/blister EUDAMEDD-P.01.25-021-06-025-RB-000-00-00 EUDAMEDChameleon Series-Dual Shaper 21mm #25/04 5pcs/blister EUDAMEDD-P.01.25-021-04-025-RB-000-00-00 EUDAMEDChameleon Series-Dual Shaper 25mm #20/04 5pcs/blister EUDAMEDD-P.01.25-025-04-020-RB-000-00-00 EUDAMEDDual Shaper 25mm #20/04 5pcs/blister EUDAMEDD-P.01.25-025-04-020-GD-000-00-00 EUDAMEDChameleon Series-Dual Shaper 25mm #25/04 5pcs/blister EUDAMEDD-P.01.25-025-04-025-RB-000-00-00 EUDAMEDChameleon Series-Dual Shaper 25mm SX,#016,#20/04,#25/04,#25/06 5pcs/blister EUDAMEDD-P.01.25-025-VT-0A0-RB-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512500361 EUDAMED06942512500392 EUDAMED06975718057445 EUDAMED06942512500385 EUDAMED06975718057438 EUDAMED06975718057421 EUDAMED06975718057452 EUDAMED06942512500378 EUDAMED06975718057469 EUDAMED06975718057483 EUDAMED
- Basic UDI-DI
- B-06942512500361 EUDAMEDB-06942512500392 EUDAMEDB-06975718057445 EUDAMEDB-06942512500385 EUDAMEDB-06975718057438 EUDAMEDB-06975718057421 EUDAMEDB-06975718057452 EUDAMEDB-06942512500378 EUDAMEDB-06975718057469 EUDAMEDB-06975718057483 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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
Dual Shaper 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-06942512500361 | 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 (10)
- EUDAMED 3c023ffd-c091-45ed-8414-686be8ca1358 61 fields · synced Aug 1, 2026
- EUDAMED cc768a83-96c2-474e-bc1a-3a0df77a9023 61 fields · synced May 17, 2026
- EUDAMED b677ffb7-0d92-427a-9ec2-0a86808bc66e 61 fields · synced May 17, 2026
- EUDAMED d7eef8bb-404a-44b3-bfcf-2c796ddcc93a 61 fields · synced May 18, 2026
- EUDAMED 9821c699-e35e-4d9a-a8dc-01360672cabf 61 fields · synced May 18, 2026
- EUDAMED 48bf265f-d4f1-4464-b7c6-0ee81cec102e 61 fields · synced May 18, 2026
- EUDAMED db0ed422-68db-4e62-868a-2fc7f79071b6 61 fields · synced May 19, 2026
- EUDAMED 66c054e4-a995-4a8b-a644-392158d2ab34 61 fields · synced May 19, 2026
- EUDAMED 5bf6a6d6-2f33-4b5d-875f-29125f2ae9b4 61 fields · synced May 19, 2026
- EUDAMED 2c9dffd1-40e1-4292-a595-dc4d363b70a2 61 fields · synced May 19, 2026