Identity
- Trade Name
- MANI U-FILES - 33mm #50 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 #50 FDA UDI
- Description
- MANI U-FILES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951515591 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951515591 EUDAMED4546951000014ZJ EUDAMED
- Unit of Use DI
- 74546951515590 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MANI U-FILES - 33mm #50 by Mani, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951515591 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951515591 | 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 0abdc989-c738-4ee4-afa6-c251885da0aa 61 fields · synced Jul 30, 2026
- EUDAMED 8a585a2b-8b92-4336-83c8-51e9d032d191 61 fields · synced May 19, 2026
- FDA UDI 906067c5-c957-4bdc-8be5-2ba58f5946f8 33 fields · synced May 30, 2026