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K Flex
EUDAMEDClass IIa (EU MDR)
Ref A330 650 925 2802 045Model File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc
Identity
- Trade Name
- K Flex EUDAMED
- Device Name
- Dental Root-Canal Instruments EUDAMED
- Model / Reference
- File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc EUDAMEDA330 650 925 2802 045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200944934 EUDAMED
- Basic UDI-DI
- 697590932SSTHandfilesJ4 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
K Flex 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 | 697590932SSTHandfilesJ4 | 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 e1ed5f3b-cec8-4250-99fd-cdef3d8f7a32 61 fields · synced Aug 2, 2026