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K-Files
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 01.154.25.010.CGModel 03.050.31.025.CT
Identity
- Trade Name
- K-FILES EUDAMEDFDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- Barbed Broaches EUDAMEDK-Files 154, 25 mm, # 10, handle SMG FDA UDI
- Model / Reference
- 03.050.31.025.CT EUDAMED01.154.25.010.CG EUDAMEDFDA UDI
- Description
- K-Files 154, 25 mm, # 10, handle SMG FDA UDI
Identifiers
- Catalog Number
- 01.154.25.010.CG FDA UDI
- Primary DI / UDI-DI
- 07640142415725 EUDAMEDFDA UDI
- Basic UDI-DI
- 7640142410301019E EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Manual endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual endodontic file/rasp, reusable
K-Files by FKG Dentaire Sàrl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7640142410301019E | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- FKG Dentaire Sàrl
- EUDAMED SRN
- CH-MF-000017925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED aeb68a78-9382-451a-a701-9fbd4ed0e88e 61 fields · synced Jul 13, 2026
- FDA UDI 81570ba2-f898-427d-b80e-9cd51bb9eb50 34 fields · synced May 30, 2026