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MANI SHORT BARBED BAORCHES - 21mm #5
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref -
by Mani, Inc.
Identity
- Trade Name
- MANI SHORT BARBED BAORCHES - 21mm #5 EUDAMEDMANI SHORT BARBED BAORCHES FDA UDI
- Generic Name
- Endodontic broach, serrated, reusable FDA UDI
- Device Name
- MANI SHORT BARBED BROACHES EUDAMEDFDA UDI
- Model / Reference
- - EUDAMED21mm #5 FDA UDI
- Description
- MANI SHORT BARBED BROACHES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951521141 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04546951521141 EUDAMED4546951000002ZB EUDAMED
- Unit of Use DI
- 74546951521140 EUDAMED
- FDA Product Code
- EKW FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic broach, serrated, reusable 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 SHORT BARBED BAORCHES - 21mm #5 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-04546951521141 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04546951521141 | 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 24dc3331-c1bb-4220-9dd9-1a7722beafa4 61 fields · synced Jul 11, 2026
- EUDAMED 923e397f-721a-4a6f-a47d-6b4077625f23 61 fields · synced May 19, 2026
- FDA UDI 04435940-03dc-475f-b640-37248d0df9a8 33 fields · synced May 29, 2026