MANI ENGINE REAMERS - 35mm #35
EUDAMEDFDA UDIClass IIa (EU MDR)
by Mani, Inc.
Identity
- Trade Name
- MANI ENGINE REAMERS - 35mm #35 EUDAMEDMANI ENGINE REAMERS FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- MANI ENGINE REAMERS EUDAMEDFDA UDIRotary SUS Files EUDAMED
- Model / Reference
- - EUDAMED35mm #35 FDA UDI
- Description
- MANI ENGINE REAMERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951513986 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951513986 EUDAMED4546951000013ZG EUDAMED
- Unit of Use DI
- 74546951513985 EUDAMED
- FDA Product Code
- EKP FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, reusable 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 ENGINE REAMERS - 35mm #35 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.
- 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
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- 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 (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04546951513986 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951513986 | 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 4f0bc53a-f77b-4cbe-bcbe-ba3a007ba7a1 61 fields · synced Jul 21, 2026
- EUDAMED aa3af6d3-9032-49c6-9ad3-99af9659dcc6 61 fields · synced May 18, 2026
- FDA UDI 591e9f99-6ebf-40c4-8e19-a07ddacd4762 33 fields · synced May 30, 2026