Identity
- Trade Name
- MANI SPREADERS - 25mm #35 EUDAMEDMANI SPREADERS FDA UDI
- Generic Name
- Manual endodontic filling material spreader FDA UDI
- Device Name
- MANI SPREADERS EUDAMEDFDA UDI
- Model / Reference
- - EUDAMED25mm #35 FDA UDI
- Description
- MANI SPREADERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951506094 EUDAMEDFDA UDI
- Basic UDI-DI
- 4546951000003ZD EUDAMEDB-04546951506094 EUDAMED
- Unit of Use DI
- 74546951506093 EUDAMED
- FDA Product Code
- EKK FDA UDI
- EMDN Code
- L159012 ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE EUDAMED
- GMDN Term
- Manual endodontic filling material spreader FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- 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
Yes
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 SPREADERS - 25mm #35 by Mani, Inc. — Class I — 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 | 4546951000003ZD | Class I | Active |
| EUDAMED | European Union | CE/MDD | 4546951000003ZD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 5cbcdb7e-86da-457a-9a31-a0acca660dd4 61 fields · synced Jul 14, 2026
- EUDAMED df4532de-ab9a-41bc-9de8-1d1e00ffec88 61 fields · synced May 16, 2026
- FDA UDI 796f54c7-e2c2-4600-a707-676a5a7277b9 33 fields · synced May 29, 2026