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MANI H-FILES - 28mm #70
EUDAMEDFDA UDIClass I (EU MDR)
Ref -Model HAND FILES
by Mani, Inc.
Identity
- Trade Name
- MANI H-FILES - 28mm #70 EUDAMEDMANI H-FILES FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- MANI H-FILES EUDAMEDFDA UDI
- Model / Reference
- HAND FILES EUDAMED- EUDAMED28MM #70 FDA UDI
- Description
- MANI H-FILES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951503369 EUDAMEDFDA UDI
- Basic UDI-DI
- 4546951000001Z9 EUDAMEDB-04546951503369 EUDAMED
- Unit of Use DI
- 74546951503368 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Manual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
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 H-FILES - 28mm #70 by Mani, Inc. — Class I — 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 | 4546951000001Z9 | Class I | Active |
| EUDAMED | European Union | CE/MDD | 4546951000001Z9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 fa53eee6-b414-4664-b632-bc4dbae7d780 61 fields · synced Jul 28, 2026
- EUDAMED e49a53a4-d9d7-46c5-ab16-b07f7c4bb276 61 fields · synced May 16, 2026
- FDA UDI e3bef037-5ea9-4bf2-9971-0e49e7222b0a 33 fields · synced May 29, 2026