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Super Files
EUDAMEDClass IIa (EU MDR)
Ref D-P.03.07-025-09-0F3-RB-000-00-00Model Chameleon Series - Super Files For Hand Use 25mm F3 6pcs/packRef CODE0131ASSTModel E01 NiTi Super Files Gold 6s 31mm Asst.Ref CODE0125F3Model E01 NiTi Super Files Gold 6s 25mm No.F3Ref CODE0121F3Model E01 NiTi Super Files Gold 6s 21mm No.F3Ref CODE0119SXModel E01 NiTi Super Files Gold 6s 19mm No.SXRef CODE0121F5Model E01 NiTi Super Files Gold 6s 21mm No.F5Ref CODE0131F3Model E01 NiTi Super Files Gold 6s 31mm No. F3Ref CODE0125ASSTModel E01 NiTi Super Files Gold 6s 25mm Asst.Model E01 NiTi Super Files Gold 6s 25mm No.F1Ref CODE0131F4Model E01 NiTi Super Files Gold 6s 31mm No. F4Ref CODE0125F5Model E01 NiTi Super Files Gold 6s 25mm No.F5Ref D-P.03.07-019-VT-0SX-SR-000-00-00Model Super Files For Hand Use 19mm SX 6pcs/packRef CODE0131F5Model E01 NiTi Super Files Gold 6s 31mm No. F5Ref CODE0125F4Model E01 NiTi Super Files Gold 6s 25mm No.F4Ref CODE0121F4Model E01 NiTi Super Files Gold 6s 21mm No.F4Ref CODE0125S1Model E01 NiTi Super Files Gold 6s 25mm No.S1Ref CODE0131F2Model E01 NiTi Super Files Gold 6s 31mm No. F2Ref D-P.01.01-021-VT-0S1-RB-000-00-00Model Chameleon Series - Super files 21mm S1 6pcs/pack
Identity
- Trade Name
- Super Files EUDAMEDNiTi Super Files Gold EUDAMED
- Device Name
- Super Files EUDAMEDDental Root Canal Instruments Files EUDAMED
- Model / Reference
- Chameleon Series - Super Files For Hand Use 25mm F3 6pcs/pack EUDAMEDD-P.03.07-025-09-0F3-RB-000-00-00 EUDAMEDE01 NiTi Super Files Gold 6s 31mm Asst. EUDAMEDCODE0131ASST EUDAMEDE01 NiTi Super Files Gold 6s 25mm No.F3 EUDAMEDCODE0125F3 EUDAMEDE01 NiTi Super Files Gold 6s 21mm No.F3 EUDAMEDCODE0121F3 EUDAMEDE01 NiTi Super Files Gold 6s 19mm No.SX EUDAMEDCODE0119SX EUDAMEDE01 NiTi Super Files Gold 6s 21mm No.F5 EUDAMEDCODE0121F5 EUDAMEDE01 NiTi Super Files Gold 6s 31mm No. F3 EUDAMEDCODE0131F3 EUDAMEDE01 NiTi Super Files Gold 6s 25mm Asst. EUDAMEDCODE0125ASST EUDAMEDE01 NiTi Super Files Gold 6s 25mm No.F1 EUDAMEDE01 NiTi Super Files Gold 6s 31mm No. F4 EUDAMEDCODE0131F4 EUDAMEDE01 NiTi Super Files Gold 6s 25mm No.F5 EUDAMEDCODE0125F5 EUDAMEDSuper Files For Hand Use 19mm SX 6pcs/pack EUDAMEDD-P.03.07-019-VT-0SX-SR-000-00-00 EUDAMEDE01 NiTi Super Files Gold 6s 31mm No. F5 EUDAMEDCODE0131F5 EUDAMEDE01 NiTi Super Files Gold 6s 25mm No.F4 EUDAMEDCODE0125F4 EUDAMEDE01 NiTi Super Files Gold 6s 21mm No.F4 EUDAMEDCODE0121F4 EUDAMEDE01 NiTi Super Files Gold 6s 25mm No.S1 EUDAMEDCODE0125S1 EUDAMEDE01 NiTi Super Files Gold 6s 31mm No. F2 EUDAMEDCODE0131F2 EUDAMEDChameleon Series - Super files 21mm S1 6pcs/pack EUDAMEDD-P.01.01-021-VT-0S1-RB-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975718055038 EUDAMED06942512502723 EUDAMED06942512502679 EUDAMED06942512502594 EUDAMED06942512502556 EUDAMED06942512502617 EUDAMED06942512502754 EUDAMED06942512502648 EUDAMED06942512502655 EUDAMED06942512502761 EUDAMED06942512502693 EUDAMED06970514911847 EUDAMED06942512502778 EUDAMED06942512502686 EUDAMED06942512502600 EUDAMED06942512502709 EUDAMED06942512502747 EUDAMED06975718053096 EUDAMED
- Basic UDI-DI
- B-06975718055038 EUDAMEDB-06942512502723 EUDAMEDB-06942512502679 EUDAMEDB-06942512502594 EUDAMEDB-06942512502556 EUDAMEDB-06942512502617 EUDAMEDB-06942512502754 EUDAMEDB-06942512502648 EUDAMEDB-06942512502655 EUDAMEDB-06942512502761 EUDAMEDB-06942512502693 EUDAMEDB-06970514911847 EUDAMEDB-06942512502778 EUDAMEDB-06942512502686 EUDAMEDB-06942512502600 EUDAMEDB-06942512502709 EUDAMEDB-06942512502747 EUDAMEDB-06975718053096 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDPoland 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
Super Files 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-06975718055038 | 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 (18)
- EUDAMED 78a888ba-0fff-45c8-80fe-072ebf3645b5 61 fields · synced Sep 18, 2026
- EUDAMED a1248be8-3a80-47bb-ae2e-9a01926889ea 61 fields · synced May 16, 2026
- EUDAMED 6277f3df-6016-4b6c-922a-1f6d8fa3698a 61 fields · synced May 16, 2026
- EUDAMED 6c3099e3-929f-4588-9e31-181efa96f86f 61 fields · synced May 16, 2026
- EUDAMED abf24fdf-709e-4797-9508-eea7db15a30c 61 fields · synced May 16, 2026
- EUDAMED 30837bae-eb27-45c6-bc28-6ba283388813 61 fields · synced May 17, 2026
- EUDAMED 186c2730-a5d6-4ae9-8d32-6bef0d9a3685 61 fields · synced May 17, 2026
- EUDAMED 30acc0f4-700d-48c6-a0f8-1b92708b1517 61 fields · synced May 17, 2026
- EUDAMED 2ff2078a-5185-42d1-899e-6fcf14b50e53 61 fields · synced May 17, 2026
- EUDAMED 38a4c743-a81a-4cff-bb47-ca3aa53eb6ff 61 fields · synced May 17, 2026
- EUDAMED 3cabefde-8213-40ca-a332-b78123fe7b34 61 fields · synced May 17, 2026
- EUDAMED 41d243ca-3bc3-4ea2-8db5-8dcff0166000 61 fields · synced May 17, 2026
- EUDAMED 768de94d-27cf-438f-9f46-e4b9f0b0c00a 61 fields · synced May 17, 2026
- EUDAMED e233796c-14f2-4074-8b4f-2f3ea2b8f45e 61 fields · synced May 18, 2026
- EUDAMED ffdf8fb4-4521-4508-b07a-d52dcdcec514 61 fields · synced May 18, 2026
- EUDAMED b7816905-ef22-4ef9-8adf-539bfadf1866 61 fields · synced May 18, 2026
- EUDAMED 5e959397-4754-48fd-b6dc-e71a51d86174 61 fields · synced May 19, 2026
- EUDAMED aaec5cf1-74fc-4374-afa0-b70531d86516 61 fields · synced Jul 12, 2026