Mb-302
by W & H Dentalwerk Bürmoos GmbH 3 variants
Ref 30310001Model 30310000
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | NumberJ021303100011 | Date29 Nov 2022 | StatusListed |
| European Union | CE/MDR EUDAMED | Number++J021AssistMB3025D J021303100011 | Date21 Jan 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Mb-302 EUDAMEDAssistina Twin MB-302 GUDID
- Generic Name
- Dental handpiece maintenance unit
- Model / Reference
- 30310000, 30310001
- Primary DI / UDI-DI
- J021303100011
- Basic UDI-DI
- ++J021AssistMB3025D
- Direct Marketing DI
- +J021303100010
- FDA Product Code
- EFB
- EMDN Code
- Z12119006 Dental cleaning/washing handpiece equipments
- GMDN Term
- Dental handpiece maintenance unit
- Device Class
- Class I
- Regulation Number
- 872.4200
- EU market of registration
- Austria
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- AT-MF-000001590
Other devices from W & H Dentalwerk Bürmoos GmbH
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No