Identity
- Trade Name
- JIZAI - 035 06 21mm EUDAMEDJIZAI FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, reusable FDA UDI
- Device Name
- MANI NiTi FILES EUDAMEDFDA UDI
- Model / Reference
- - EUDAMED035 06 21mm FDA UDI
- Description
- MANI NiTi FILES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951605858 EUDAMEDFDA UDI
- Basic UDI-DI
- 4546951000015ZL EUDAMEDB-04546951605858 EUDAMED
- Unit of Use DI
- 74546951605857 EUDAMED
- FDA Product Code
- EKS 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
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
EUDAMED
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
JIZAI - 035 06 21mm by Mani, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4546951000015ZL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4546951000015ZL | 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 1ba4c7a2-2f99-4706-976b-77c03c76cd03 61 fields · synced Jul 14, 2026
- EUDAMED 15f563ed-63a3-49f5-a034-3c269ef50b61 61 fields · synced May 19, 2026
- FDA UDI 7e4b8998-577e-40a3-a2e8-eab7caa42fc0 33 fields · synced May 30, 2026