MANI U-FILES - 33mm #15-40
EUDAMEDFDA UDIClass IIa (EU MDR)
by Mani, Inc.
Identity
- Trade Name
- MANI U-FILES - 33mm #15-40 EUDAMEDMANI U-FILES FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
- Device Name
- MANI U-FILES EUDAMEDFDA UDI
- Model / Reference
- - EUDAMED33MM #40 FDA UDI
- Description
- MANI U-FILES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951517700 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951517700 EUDAMED4546951000014ZJ EUDAMED
- Unit of Use DI
- 74546951517709 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Manual endodontic file/rasp, reusable
MANI U-FILES - 33mm #15-40 by Mani, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
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- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951517700 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951517700 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 6c36ff29-b8a8-47dc-b507-6beb7fd2d496 61 fields · synced Jun 19, 2026
- EUDAMED fdfc62a3-67b7-4250-aae7-a847f44c13b1 61 fields · synced May 19, 2026
- FDA UDI b328dcba-c61c-47c5-8ebd-b553cf3792c2 33 fields · synced May 30, 2026