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i File x
EUDAMEDClass IIa (EU MDR)
Ref V497 201 954 1507 020、V497 201 954 2504 015、V497 201 954 2504 020、V497 201 954 2504 025Model ET Files、V BLUE、MTF、TG6、TH6、TF4 etc
Identity
- Trade Name
- i File x EUDAMED
- Device Name
- Dental Root-Canal Instruments EUDAMED
- Model / Reference
- ET Files、V BLUE、MTF、TG6、TH6、TF4 etc EUDAMEDV497 201 954 1507 020、V497 201 954 2504 015、V497 201 954 2504 020、V497 201 954 2504 025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200903429 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
i File x 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 cc058255-f3fb-4b8f-baa8-1b01881c2334 61 fields · synced Sep 17, 2026