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MANI GATES DRILLS - 32mm #3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref -Model Peeso Gates
by Mani, Inc.
Identity
- Trade Name
- MANI GATES DRILLS - 32mm #3 EUDAMEDMANI GATES DRILLS FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- MANI GATES DRILLS EUDAMEDFDA UDI
- Model / Reference
- - EUDAMEDPeeso Gates EUDAMED32mm #3 FDA UDI
- Description
- MANI GATES DRILLS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951513238 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951513238 EUDAMED4546951000016ZN EUDAMED
- Unit of Use DI
- 74546951513237 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
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 GATES DRILLS - 32mm #3 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-04546951513238 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951513238 | 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 8bd4357a-3069-4130-9456-1e1f22d817c2 61 fields · synced Jul 29, 2026
- EUDAMED b415eaf6-48ba-4b8d-adbb-4f6e77748955 61 fields · synced May 18, 2026
- FDA UDI 2fb86997-d6ee-4d41-91a5-e81ca62bf874 33 fields · synced May 30, 2026