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DK Files
EUDAMEDClass IIa (EU MDR)
Ref Z490 201 929 3104 020Model ET Files、V BLUE、MTF、TG6、TH6、TF4 etc
Identity
- Trade Name
- DK Files EUDAMED
- Device Name
- Dental Root-Canal Instruments EUDAMED
- Model / Reference
- ET Files、V BLUE、MTF、TG6、TH6、TF4 etc EUDAMEDZ490 201 929 3104 020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200910922 EUDAMED
- Basic UDI-DI
- 697590932NiTiRotary96 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
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DK Files by Shanwei Perfect Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697590932NiTiRotary96 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanwei Perfect Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000033003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 00ecb895-e416-498d-bbdc-148b5046597e 61 fields · synced Aug 3, 2026