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MANI PASTE CARRIERS - 21mm #25
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref -
by Mani, Inc.
Identity
- Trade Name
- MANI PASTE CARRIERS - 21mm #25 EUDAMEDMANI PASTE CARRIERS FDA UDI
- Generic Name
- Endodontic obturation material distribution endpiece, reusable FDA UDI
- Device Name
- MANI PASTE CARRIERS EUDAMEDFDA UDI
- Model / Reference
- - EUDAMED21mm #25 FDA UDI
- Description
- MANI PASTE CARRIERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951515607 EUDAMEDFDA UDI
- Basic UDI-DI
- 4546951000020ZD EUDAMEDB-04546951515607 EUDAMED
- Unit of Use DI
- 74546951515606 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic obturation material distribution endpiece, 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
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 PASTE CARRIERS - 21mm #25 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 | 4546951000020ZD | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 4546951000020ZD | 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 e111c0c5-2761-41da-9df8-408aae63055c 61 fields · synced Jul 22, 2026
- EUDAMED ee0fb132-6c95-4fa1-a414-48200aba812a 61 fields · synced May 17, 2026
- FDA UDI 26aafad8-5172-413f-bfa9-1a9ca157bada 33 fields · synced May 30, 2026