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NiTi D-Shaper Files Gold
EUDAMEDClass IIa (EU MDR)
Ref CODE2521S1Model E25 NiTi D-Shaper Files Gold 6s 21mm No.S1Ref CODE2521S4Model E25 NiTi D-Shaper Files Gold 6s 21mm No.S4Ref CODE2521ASSTModel E25 NiTi D-Shaper Files Gold 6s 21mm Asst.
Identity
- Trade Name
- NiTi D-Shaper Files Gold EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E25 NiTi D-Shaper Files Gold 6s 21mm No.S1 EUDAMEDCODE2521S1 EUDAMEDE25 NiTi D-Shaper Files Gold 6s 21mm No.S4 EUDAMEDCODE2521S4 EUDAMEDE25 NiTi D-Shaper Files Gold 6s 21mm Asst. EUDAMEDCODE2521ASST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512504598 EUDAMED06942512504628 EUDAMED06942512504581 EUDAMED
- Basic UDI-DI
- B-06942512504598 EUDAMEDB-06942512504628 EUDAMEDB-06942512504581 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 D-Shaper Files Gold 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-06942512504598 | 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 (3)
- EUDAMED 4ef95a2d-db72-429b-89b3-921928ef75a1 61 fields · synced Jul 29, 2026
- EUDAMED 6a853174-d48c-4116-920e-f510aa5128b4 61 fields · synced May 17, 2026
- EUDAMED deb6afe8-ab7b-4bf2-96ec-32e2f408de34 61 fields · synced May 18, 2026