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NiTi Super Files Blue
EUDAMEDClass IIa (EU MDR)
Ref CODE0225F4Model E02 NiTi Super Files Blue 6s 25mm No.F4Ref CODE0219SXModel E02 NiTi Super Files Blue 6s 19mm No.SXRef CODE0221F3Model E02 NiTi Super Files Blue 6s 21mm No.F3Ref CODE0225ASSTModel E02 NiTi Super Files Blue 6s 25mm Asst.Ref CODE0231F4Model E02 NiTi Super Files Blue 6s 31mm F4Ref CODE0231ASSTModel E02 NiTi Super Files Blue 6s 31mm Asst.Ref CODE0225F5Model E02 NiTi Super Files Blue 6s 25mm No.F5Ref CODE0225S2Model E02 NiTi Super Files Blue 6s 25mm No.S2Ref CODE0225S1Model E02 NiTi Super Files Blue 6s 25mm No.S1Ref CODE0221S1Model E02 NiTi Super Files Blue 6s 21mm No.S1Ref CODE0225F2Model E02 NiTi Super Files Blue 6s 25mm No.F2Ref CODE0231S2Model E02 NiTi Super Files Blue 6s 31mm S2Ref CODE0221F4Model E02 NiTi Super Files Blue 6s 21mm No.F4Ref CODE0231S1Model E02 NiTi Super Files Blue 6s 31mm S1Ref CODE0225F3Model E02 NiTi Super Files Blue 6s 25mm No.F3
Identity
- Trade Name
- NiTi Super Files Blue EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E02 NiTi Super Files Blue 6s 25mm No.F4 EUDAMEDCODE0225F4 EUDAMEDE02 NiTi Super Files Blue 6s 19mm No.SX EUDAMEDCODE0219SX EUDAMEDE02 NiTi Super Files Blue 6s 21mm No.F3 EUDAMEDCODE0221F3 EUDAMEDE02 NiTi Super Files Blue 6s 25mm Asst. EUDAMEDCODE0225ASST EUDAMEDE02 NiTi Super Files Blue 6s 31mm F4 EUDAMEDCODE0231F4 EUDAMEDE02 NiTi Super Files Blue 6s 31mm Asst. EUDAMEDCODE0231ASST EUDAMEDE02 NiTi Super Files Blue 6s 25mm No.F5 EUDAMEDCODE0225F5 EUDAMEDE02 NiTi Super Files Blue 6s 25mm No.S2 EUDAMEDCODE0225S2 EUDAMEDE02 NiTi Super Files Blue 6s 25mm No.S1 EUDAMEDCODE0225S1 EUDAMEDE02 NiTi Super Files Blue 6s 21mm No.S1 EUDAMEDCODE0221S1 EUDAMEDE02 NiTi Super Files Blue 6s 25mm No.F2 EUDAMEDCODE0225F2 EUDAMEDE02 NiTi Super Files Blue 6s 31mm S2 EUDAMEDCODE0231S2 EUDAMEDE02 NiTi Super Files Blue 6s 21mm No.F4 EUDAMEDCODE0221F4 EUDAMEDE02 NiTi Super Files Blue 6s 31mm S1 EUDAMEDCODE0231S1 EUDAMEDE02 NiTi Super Files Blue 6s 25mm No.F3 EUDAMEDCODE0225F3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512502938 EUDAMED06942512502808 EUDAMED06942512502846 EUDAMED06942512502891 EUDAMED06942512503010 EUDAMED06942512502976 EUDAMED06942512502945 EUDAMED06942512502969 EUDAMED06942512502952 EUDAMED06942512502877 EUDAMED06942512502914 EUDAMED06942512503041 EUDAMED06942512502853 EUDAMED06942512503034 EUDAMED06942512502921 EUDAMED
- Basic UDI-DI
- B-06942512502938 EUDAMEDB-06942512502808 EUDAMEDB-06942512502846 EUDAMEDB-06942512502891 EUDAMEDB-06942512503010 EUDAMEDB-06942512502976 EUDAMEDB-06942512502945 EUDAMEDB-06942512502969 EUDAMEDB-06942512502952 EUDAMEDB-06942512502877 EUDAMEDB-06942512502914 EUDAMEDB-06942512503041 EUDAMEDB-06942512502853 EUDAMEDB-06942512503034 EUDAMEDB-06942512502921 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
NiTi Super Files Blue 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-06942512502938 | 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 (15)
- EUDAMED 825d86e3-58d6-4203-8194-cb34b49fb2e7 61 fields · synced Aug 1, 2026
- EUDAMED a843d001-5f18-4a5e-8460-c09bf9798a76 61 fields · synced May 11, 2026
- EUDAMED c58586d2-2be8-4dc6-a6ed-98327df4ea97 61 fields · synced May 11, 2026
- EUDAMED 76099111-c110-4655-9dfb-cf3a5baf4579 61 fields · synced May 16, 2026
- EUDAMED 9dbba811-0c6e-49f8-a242-81a7264181bb 61 fields · synced May 16, 2026
- EUDAMED dd428e32-fa52-4e98-b8a7-0289c3115cf2 61 fields · synced May 17, 2026
- EUDAMED c5ff1d0e-9a4a-4fd2-a1a4-43e0a1e16868 61 fields · synced May 17, 2026
- EUDAMED 92c7ee6c-3953-4f37-905f-6184ac1e2f14 61 fields · synced May 17, 2026
- EUDAMED 39673d4c-0bde-4898-bbb4-0a5d870d702e 61 fields · synced May 18, 2026
- EUDAMED 9bbe8192-9a59-411c-a77f-b9c23e41b44c 61 fields · synced May 18, 2026
- EUDAMED ce34a7b4-2c25-4b63-961d-d913336268b3 61 fields · synced May 18, 2026
- EUDAMED d3992aa0-34bb-4a8d-87fe-d6b8a222d3dd 61 fields · synced May 18, 2026
- EUDAMED 74c0546c-b362-43da-868a-a17f9f11bd43 61 fields · synced May 18, 2026
- EUDAMED b7c94a09-a5f0-4f77-86f9-29f471ce1f2f 61 fields · synced May 19, 2026
- EUDAMED 1c576e33-2a16-47db-b9be-a035365a712e 61 fields · synced May 19, 2026