Identity
- Trade Name
- MANI SPREADERS - 21mm #30 EUDAMEDMANI SPREADERS FDA UDI
- Generic Name
- Manual endodontic filling material spreader FDA UDI
- Device Name
- MANI SPREADERS EUDAMEDFDA UDI
- Model / Reference
- - EUDAMED21mm #30 FDA UDI
- Description
- MANI SPREADERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951506018 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951506018 EUDAMED4546951000003ZD EUDAMED
- Unit of Use DI
- 74546951506017 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 IIa EUDAMEDClass I EUDAMEDFDA 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
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 - 21mm #30 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-04546951506018 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951506018 | 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 5c3b0ae0-0db5-4918-b2c7-47b4b1af9cc8 61 fields · synced Aug 2, 2026
- EUDAMED 8eb8f5ba-61be-4b00-87e1-517a44562655 61 fields · synced May 18, 2026
- FDA UDI 906fc0fe-a79b-4785-9e30-147431245f7d 33 fields · synced May 30, 2026