Identity
- Trade Name
- MANI U-FILES - 27mm #25 EUDAMED
- Device Name
- MANI U-FILES EUDAMED
- Model / Reference
- - EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951515492 EUDAMED
- Basic UDI-DI
- B-04546951515492 EUDAMED4546951000014ZJ EUDAMED
- Unit of Use DI
- 74546951515491 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Manual endodontic file/rasp, reusable
MANI U-FILES - 27mm #25 by Mani, Inc. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
- K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
- REAMERS — DiaDent Group International · Class I
- K-Files — MICRO MEGA · Class I
- Hand instrument K-file — TULSA DENTAL PRODUCTS LLC · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04546951515492 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04546951515492 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED ddf33bc5-9521-4d77-b50d-7a0b962f62a7 61 fields · synced Jun 18, 2026
- EUDAMED 752ac4ac-e4e6-46dd-bea5-1a223248e0ed 61 fields · synced May 17, 2026