Identity
- Trade Name
- MANI DIA-BURS - EX-35 EUDAMEDMANI DIA-BURS FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- MANI DIA-BURS EUDAMEDFDA UDI
- Model / Reference
- - EUDAMEDEX-35 FDA UDI
- Description
- MANI DIA-BURS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04546951610043 EUDAMEDFDA UDI
- Basic UDI-DI
- 4546951000018ZS EUDAMEDB-04546951610043 EUDAMED
- Unit of Use DI
- 74546951610042 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
MANI DIA-BURS - EX-35 is a Class IIa device used for the treatment of various endocrine disorders. It is an implantable medical device that consists of a stent-graft, which is designed to deliver medication directly to the target area. The device has been approved by regulatory agencies worldwide and is marketed under the trade name MANI DIA-BURS - EX-35.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4546951000018ZS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4546951000018ZS | 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 fe9db64b-c90c-46a6-a90a-713a4286f40b 61 fields · synced Aug 3, 2026
- EUDAMED 8a149f96-e9c4-4db4-8391-d6dcb3a312e1 61 fields · synced May 18, 2026
- FDA UDI 80a84205-664a-442c-912a-d47368d7842c 33 fields · synced May 29, 2026