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S-Feile NiTi
EUDAMEDClass IIa (EU MDR)
Ref SF.31.SETModel SF.31.SET S-Feile NiTi 31mm SX-F3Ref SF.19.SXModel SF.19.SX S-Feile NiTi 19mm SXRef SF.31.S2Model SF.31.S2 S-Feile NiTi 31mm S2Ref SF.25.F5Model SF.25.F5 S-Feile NiTi 25mm F5Ref SF.25.F2Model SF.25.F2 S-Feile NiTi 25mm F2Ref SF.31.F4Model SF.31.F4 S-Feile NiTi 31mm F4Ref SF.25.S2Model SF.25.S2 S-Feile NiTi 25mm S2Ref SF.21.SETModel SF.21.SET S-Feile NiTi 21mm SX-F3Ref SF.25.SETModel SF.25.SET S-Feile NiTi 25mm SX-F3Ref SF.21.F5Model SF.21.F5 S-Feile NiTi 21mm F5Ref SF.25.S1Model SF.25.S1 S-Feile NiTi 25mm S1Ref SF.31.F1Model SF.31.F1 S-Feile NiTi 31mm F1Ref SF.31.F3Model SF.31.F3 S-Feile NiTi 31mm F3
Identity
- Trade Name
- S-Feile NiTi EUDAMED
- Device Name
- S-Feile NiTi EUDAMED
- Model / Reference
- SF.31.SET S-Feile NiTi 31mm SX-F3 EUDAMEDSF.31.SET EUDAMEDSF.19.SX S-Feile NiTi 19mm SX EUDAMEDSF.19.SX EUDAMEDSF.31.S2 S-Feile NiTi 31mm S2 EUDAMEDSF.31.S2 EUDAMEDSF.25.F5 S-Feile NiTi 25mm F5 EUDAMEDSF.25.F5 EUDAMEDSF.25.F2 S-Feile NiTi 25mm F2 EUDAMEDSF.25.F2 EUDAMEDSF.31.F4 S-Feile NiTi 31mm F4 EUDAMEDSF.31.F4 EUDAMEDSF.25.S2 S-Feile NiTi 25mm S2 EUDAMEDSF.25.S2 EUDAMEDSF.21.SET S-Feile NiTi 21mm SX-F3 EUDAMEDSF.21.SET EUDAMEDSF.25.SET S-Feile NiTi 25mm SX-F3 EUDAMEDSF.25.SET EUDAMEDSF.21.F5 S-Feile NiTi 21mm F5 EUDAMEDSF.21.F5 EUDAMEDSF.25.S1 S-Feile NiTi 25mm S1 EUDAMEDSF.25.S1 EUDAMEDSF.31.F1 S-Feile NiTi 31mm F1 EUDAMEDSF.31.F1 EUDAMEDSF.31.F3 S-Feile NiTi 31mm F3 EUDAMEDSF.31.F3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512511251 EUDAMED06942512511084 EUDAMED06942512511275 EUDAMED06942512511244 EUDAMED06942512511213 EUDAMED06942512511312 EUDAMED06942512511190 EUDAMED06942512511091 EUDAMED06942512511176 EUDAMED06942512511169 EUDAMED06942512511183 EUDAMED06942512511282 EUDAMED06942512511305 EUDAMED
- Basic UDI-DI
- B-06942512511251 EUDAMEDB-06942512511084 EUDAMEDB-06942512511275 EUDAMEDB-06942512511244 EUDAMEDB-06942512511213 EUDAMEDB-06942512511312 EUDAMEDB-06942512511190 EUDAMEDB-06942512511091 EUDAMEDB-06942512511176 EUDAMEDB-06942512511169 EUDAMEDB-06942512511183 EUDAMEDB-06942512511282 EUDAMEDB-06942512511305 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
S-Feile NiTi 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-06942512511251 | 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 (13)
- EUDAMED 03e7bc68-43f6-4f68-91ea-1ffd3a139493 61 fields · synced Aug 3, 2026
- EUDAMED 1489f358-d112-48a9-b072-287750d243b5 61 fields · synced May 11, 2026
- EUDAMED bf3e714f-e567-4152-a37b-dfeb72108b93 61 fields · synced May 16, 2026
- EUDAMED 9c1836d4-f8c5-4ff8-99d9-81a1235e071e 61 fields · synced May 17, 2026
- EUDAMED 1a03c03c-327f-44ab-b9d4-74c2e84fab85 61 fields · synced May 17, 2026
- EUDAMED da4897e3-b2ce-4f96-b70a-afe29e2c6f64 61 fields · synced May 17, 2026
- EUDAMED 818451ca-a10f-45c5-a82c-4098d2f8db8a 61 fields · synced May 17, 2026
- EUDAMED 56c4ba30-72ec-4625-b415-fc39707f6ee9 61 fields · synced May 17, 2026
- EUDAMED 0c68783f-842a-4df5-810f-e33f75372e40 61 fields · synced May 18, 2026
- EUDAMED 21536353-4f62-4dfb-84a0-14a3e34d4873 61 fields · synced May 18, 2026
- EUDAMED d5a2b9c7-a1f6-442b-b47a-d707c47bd348 61 fields · synced May 18, 2026
- EUDAMED c960496e-b26e-4a05-812a-ab56324e2779 61 fields · synced May 18, 2026
- EUDAMED a9c84e52-b528-4010-a674-5378c1ed366d 61 fields · synced May 18, 2026