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Barbed Broaches
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 03.050.31.050.CTModel 03.050.31.025.CT
Identity
- Trade Name
- Barbed Broaches EUDAMEDFDA UDI
- Generic Name
- Endodontic broach, serrated, single-use FDA UDI
- Device Name
- Barbed Broaches EUDAMEDBarbed Broaches 50, 31 mm, # 50, handle CT FDA UDI
- Model / Reference
- 03.050.31.025.CT EUDAMED03.050.31.050.CT EUDAMEDFDA UDI
- Description
- Barbed Broaches 50, 31 mm, # 50, handle CT FDA UDI
Identifiers
- Catalog Number
- 03.050.31.050.CT FDA UDI
- Primary DI / UDI-DI
- 07640142421269 EUDAMEDFDA UDI
- Basic UDI-DI
- 7640142410301019E EUDAMED
- FDA Product Code
- EKW FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Endodontic broach, serrated, 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
Barbed Broaches by FKG Dentaire Sàrl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 6f04de1f-3f3e-4ce7-ac1f-e212be4db55e 61 fields · synced Oct 6, 2026
- FDA UDI dcddf018-3d96-4c27-8848-51688c9fa2fe 34 fields · synced May 30, 2026