MANI GATES DRILLS - 32mm #2
EUDAMEDFDA UDIClass IIa (EU MDR)
by Mani, Inc.
Identity
- Trade Name
- MANI GATES DRILLS - 32mm #2 EUDAMEDMANI GATES DRILLS FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- MANI GATES DRILLS EUDAMEDFDA UDI
- Model / Reference
- Peeso Gates EUDAMED- EUDAMED32mm #2 FDA UDI
- Description
- MANI GATES DRILLS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951513207 EUDAMEDFDA UDI
- Basic UDI-DI
- 4546951000016ZN EUDAMEDB-04546951513207 EUDAMED
- Unit of Use DI
- 74546951513206 EUDAMED
- FDA Product Code
- DZA 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
- 872.4130 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
Yes
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 GATES DRILLS - 32mm #2 by Mani, Inc. — Class IIa — MDD, MDR, 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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- 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/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4546951000016ZN | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4546951000016ZN | 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 c57bd64c-f460-401f-9086-d514ff450f01 61 fields · synced Jul 23, 2026
- EUDAMED 65912581-4442-4ed1-a156-c33754b4e6f9 61 fields · synced May 18, 2026
- FDA UDI 6e5378ee-d9cb-4893-8dd1-0ebcd9a369df 33 fields · synced May 30, 2026