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Super Files II
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.02-031-07-PX3-SR-000-00-00Model Super Files II 31mm X3 3pcs/packRef D-P.01.02-021-VT-0A0-RB-000-00-00Model Chameleon Series -Super Files II 21mm X1-X3 6pcs/packRef D-P.01.02-031-04-PX1-SR-000-00-00Model Super Files II 31mm X1 3pcs/packRef D-P.01.02-025-06-PX5-RB-000-00-00Model Chameleon Series -Super Files II 25mm X5 6pcs/packRef D-P.01.02-021-04-PX1-SR-000-00-00Model Super Files II 21mm X1 3pcs/packRef D-P.01.02-031-06-PX5-RB-000-00-00Model Chameleon Series -Super Files II 31mm X5 6pcs/packRef D-P.01.02-031-07-PX3-RB-000-00-00Model Chameleon Series -Super Files II 31mm X3 6pcs/packRef D-P.01.02-025-04-PX1-GD-000-00-00Model Super Files II Gold 25mm X1 6pcs/packRef D-P.01.02-021-06-PX2-SR-000-00-00Model Super Files II 21mm X2 3pcs/packRef D-P.01.02-025-06-PX2-RB-000-00-00Model Chameleon Series -Super Files II 25mm X2 6pcs/packRef D-P.01.02-025-04-PX1-RB-000-00-00Model Chameleon Series -Super Files II 25mm X1 6pcs/packRef D-P.01.02-031-06-PX2-SR-000-00-00Model Super Files II 31mm X2 3pcs/packRef D-P.01.02-021-06-PX4-SR-000-00-00Model Super Files II 21mm X4 3pcs/packRef D-P.01.02-025-07-PX3-RB-000-00-00Model Chameleon Series -Super Files II 25mm X3 6pcs/packRef D-P.01.02-021-06-PX4-RB-000-00-00Model Chameleon Series -Super Files II 21mm X4 6pcs/packRef D-P.01.02-025-06-PX2-SR-000-00-00Model Super Files II 25mm X2 3pcs/packRef D-P.01.02-021-06-PX5-SR-000-00-00Model Super Files II 21mm X5 3pcs/packRef D-P.01.02-031-06-PX4-SR-000-00-00Model Super Files II 31mm X4 3pcs/packRef D-P.01.02-031-VT-0A0-GD-000-00-00Model Super Files II Gold 31mm X1-X3 6pcs/packRef D-P.01.02-021-07-PX3-RB-000-00-00Model Chameleon Series -Super Files II 21mm X3 6pcs/packRef D-P.01.02-025-06-PX4-RB-000-00-00Model Chameleon Series -Super Files II 25mm X4 6pcs/packRef D-P.01.02-025-VT-0A0-RB-000-00-00Model Chameleon Series -Super Files II 25mm X1-X3 6pcs/packRef D-P.01.02-025-06-PX2-GD-000-00-00Model Super Files II Gold 25mm X2 6pcs/packRef D-P.01.02-025-06-PX4-GD-000-00-00Model Super Files II Gold 25mm X4 6pcs/packRef D-P.01.02-025-07-PX3-GD-000-00-00Model Super Files II Gold 25mm X3 6pcs/packRef D-P.01.02-025-06-PX5-SR-000-00-00Model Super Files II 25mm X5 3pcs/packRef D-P.01.02-025-07-PX3-SR-000-00-00Model Super Files II 25mm X3 3pcs/packRef D-P.01.02-021-06-PX5-RB-000-00-00Model Chameleon Series -Super Files II 21mm X5 6pcs/pack
Identity
- Trade Name
- Super Files II EUDAMED
- Device Name
- Super Files II EUDAMED
- Model / Reference
- Super Files II 31mm X3 3pcs/pack EUDAMEDD-P.01.02-031-07-PX3-SR-000-00-00 EUDAMEDChameleon Series -Super Files II 21mm X1-X3 6pcs/pack EUDAMEDD-P.01.02-021-VT-0A0-RB-000-00-00 EUDAMEDSuper Files II 31mm X1 3pcs/pack EUDAMEDD-P.01.02-031-04-PX1-SR-000-00-00 EUDAMEDChameleon Series -Super Files II 25mm X5 6pcs/pack EUDAMEDD-P.01.02-025-06-PX5-RB-000-00-00 EUDAMEDSuper Files II 21mm X1 3pcs/pack EUDAMEDD-P.01.02-021-04-PX1-SR-000-00-00 EUDAMEDChameleon Series -Super Files II 31mm X5 6pcs/pack EUDAMEDD-P.01.02-031-06-PX5-RB-000-00-00 EUDAMEDChameleon Series -Super Files II 31mm X3 6pcs/pack EUDAMEDD-P.01.02-031-07-PX3-RB-000-00-00 EUDAMEDSuper Files II Gold 25mm X1 6pcs/pack EUDAMEDD-P.01.02-025-04-PX1-GD-000-00-00 EUDAMEDSuper Files II 21mm X2 3pcs/pack EUDAMEDD-P.01.02-021-06-PX2-SR-000-00-00 EUDAMEDChameleon Series -Super Files II 25mm X2 6pcs/pack EUDAMEDD-P.01.02-025-06-PX2-RB-000-00-00 EUDAMEDChameleon Series -Super Files II 25mm X1 6pcs/pack EUDAMEDD-P.01.02-025-04-PX1-RB-000-00-00 EUDAMEDSuper Files II 31mm X2 3pcs/pack EUDAMEDD-P.01.02-031-06-PX2-SR-000-00-00 EUDAMEDSuper Files II 21mm X4 3pcs/pack EUDAMEDD-P.01.02-021-06-PX4-SR-000-00-00 EUDAMEDChameleon Series -Super Files II 25mm X3 6pcs/pack EUDAMEDD-P.01.02-025-07-PX3-RB-000-00-00 EUDAMEDChameleon Series -Super Files II 21mm X4 6pcs/pack EUDAMEDD-P.01.02-021-06-PX4-RB-000-00-00 EUDAMEDSuper Files II 25mm X2 3pcs/pack EUDAMEDD-P.01.02-025-06-PX2-SR-000-00-00 EUDAMEDSuper Files II 21mm X5 3pcs/pack EUDAMEDD-P.01.02-021-06-PX5-SR-000-00-00 EUDAMEDSuper Files II 31mm X4 3pcs/pack EUDAMEDD-P.01.02-031-06-PX4-SR-000-00-00 EUDAMEDSuper Files II Gold 31mm X1-X3 6pcs/pack EUDAMEDD-P.01.02-031-VT-0A0-GD-000-00-00 EUDAMEDChameleon Series -Super Files II 21mm X3 6pcs/pack EUDAMEDD-P.01.02-021-07-PX3-RB-000-00-00 EUDAMEDChameleon Series -Super Files II 25mm X4 6pcs/pack EUDAMEDD-P.01.02-025-06-PX4-RB-000-00-00 EUDAMEDChameleon Series -Super Files II 25mm X1-X3 6pcs/pack EUDAMEDD-P.01.02-025-VT-0A0-RB-000-00-00 EUDAMEDSuper Files II Gold 25mm X2 6pcs/pack EUDAMEDD-P.01.02-025-06-PX2-GD-000-00-00 EUDAMEDSuper Files II Gold 25mm X4 6pcs/pack EUDAMEDD-P.01.02-025-06-PX4-GD-000-00-00 EUDAMEDSuper Files II Gold 25mm X3 6pcs/pack EUDAMEDD-P.01.02-025-07-PX3-GD-000-00-00 EUDAMEDSuper Files II 25mm X5 3pcs/pack EUDAMEDD-P.01.02-025-06-PX5-SR-000-00-00 EUDAMEDSuper Files II 25mm X3 3pcs/pack EUDAMEDD-P.01.02-025-07-PX3-SR-000-00-00 EUDAMEDChameleon Series -Super Files II 21mm X5 6pcs/pack EUDAMEDD-P.01.02-021-06-PX5-RB-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514913230 EUDAMED06975718052655 EUDAMED06970514913216 EUDAMED06975718052785 EUDAMED06970514911700 EUDAMED06975718052853 EUDAMED06975718052839 EUDAMED06970514910918 EUDAMED06970514913100 EUDAMED06975718052754 EUDAMED06975718052747 EUDAMED06970514913223 EUDAMED06970514913124 EUDAMED06975718052761 EUDAMED06975718052709 EUDAMED06970514913179 EUDAMED06970514913131 EUDAMED06970514913247 EUDAMED06970514919942 EUDAMED06975718052693 EUDAMED06975718052778 EUDAMED06975718052723 EUDAMED06970514911403 EUDAMED06970514911083 EUDAMED06970514911304 EUDAMED06970514913209 EUDAMED06970514913186 EUDAMED06975718052716 EUDAMED
- Basic UDI-DI
- B-06970514913230 EUDAMEDB-06975718052655 EUDAMEDB-06970514913216 EUDAMEDB-06975718052785 EUDAMEDB-06970514911700 EUDAMEDB-06975718052853 EUDAMEDB-06975718052839 EUDAMEDB-06970514910918 EUDAMEDB-06970514913100 EUDAMEDB-06975718052754 EUDAMEDB-06975718052747 EUDAMEDB-06970514913223 EUDAMEDB-06970514913124 EUDAMEDB-06975718052761 EUDAMEDB-06975718052709 EUDAMEDB-06970514913179 EUDAMEDB-06970514913131 EUDAMEDB-06970514913247 EUDAMEDB-06970514919942 EUDAMEDB-06975718052693 EUDAMEDB-06975718052778 EUDAMEDB-06975718052723 EUDAMEDB-06970514911403 EUDAMEDB-06970514911083 EUDAMEDB-06970514911304 EUDAMEDB-06970514913209 EUDAMEDB-06970514913186 EUDAMEDB-06975718052716 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
Super Files II 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-06970514913230 | 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 (28)
- EUDAMED 678706df-f5fe-45e9-857e-cf7e4fc12287 61 fields · synced Sep 18, 2026
- EUDAMED 0c57d1de-6091-468a-9ed7-311b5d3e85b3 61 fields · synced May 11, 2026
- EUDAMED 6896b1f1-b873-4654-9a34-c633fcb2b657 61 fields · synced May 16, 2026
- EUDAMED 2ac2b731-10ac-4f47-8843-1aaef1fe5add 61 fields · synced May 16, 2026
- EUDAMED 4260a802-3847-4625-9bad-8da9b0255884 61 fields · synced May 17, 2026
- EUDAMED 3bdecad4-dfb9-4975-9cfa-58d52516b9fe 61 fields · synced May 17, 2026
- EUDAMED 7a6fa621-4b70-4fe8-acff-6ad5fb5378e2 61 fields · synced May 17, 2026
- EUDAMED 9ab55a64-8c8a-4254-aadd-9f9c5c4133c9 61 fields · synced May 17, 2026
- EUDAMED 05f605f9-e8ed-4e30-a3b8-68d39bb510a1 61 fields · synced May 17, 2026
- EUDAMED e473b8a4-12f7-49ff-aecb-357f02c01ac3 61 fields · synced May 17, 2026
- EUDAMED 7251807f-d13b-4bd0-955a-d31e961a037a 61 fields · synced May 17, 2026
- EUDAMED 291c8e5c-2afa-41df-8cec-7e976798da3f 61 fields · synced May 17, 2026
- EUDAMED fb422813-d677-49e5-b77c-86fff5b51636 61 fields · synced May 17, 2026
- EUDAMED 0188562c-9bd9-4823-bb66-2880c8fbba32 61 fields · synced May 17, 2026
- EUDAMED 886083f2-6db2-44f5-abff-ebd0509b4240 61 fields · synced May 17, 2026
- EUDAMED f58f8b79-7bc3-4998-a52c-02cc0256dd64 61 fields · synced May 17, 2026
- EUDAMED 3d929c22-f2c1-4617-8cfe-3a787109d00b 61 fields · synced May 18, 2026
- EUDAMED 640ce88e-5746-4f1e-884b-f45cfe6aab99 61 fields · synced May 18, 2026
- EUDAMED 9d5bd68b-24d0-4eeb-ae1d-d061659255d7 61 fields · synced May 18, 2026
- EUDAMED 70f4a0d2-c26f-4402-9db6-a50e2ff27428 61 fields · synced May 19, 2026
- EUDAMED 6919bed2-42e4-4fe3-9357-224a88298e3e 61 fields · synced May 19, 2026
- EUDAMED 08465f03-a758-44e7-b293-3c43b719b51d 61 fields · synced May 19, 2026
- EUDAMED 23680fb1-ca27-485e-b505-a68f18f81553 61 fields · synced May 19, 2026
- EUDAMED 6b0c902c-9ec5-4a27-9dc2-66113debab0e 61 fields · synced May 19, 2026
- EUDAMED a82be095-7faf-49ba-a212-d50a0af34cd1 61 fields · synced May 19, 2026
- EUDAMED 2d0cb352-b20a-44bf-a2b9-a149bd2546ad 61 fields · synced May 19, 2026
- EUDAMED 64739602-deef-4aaf-807e-c0ce17e80286 61 fields · synced May 19, 2026
- EUDAMED 7f052678-5e59-4ac8-af70-54c189a03887 61 fields · synced May 19, 2026