Wp-66 M
by W & H Dentalwerk Bürmoos GmbH
Ref 30190000Model 10114403
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 |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++J021P0001PZ J021301900001 | Date30 Mar 2022 | StatusActive |
| United States | GUDID listing GUDID | NumberJ021301900001 | Date10 Jan 2022 | StatusListed |
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- Withdrawn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
- Wp-66 M EUDAMEDWP-66 M Proxeo 4:1 GUDID
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric
- Device Name
- Hp-44 M
- Model / Reference
- 10114403, 30190000
- Primary DI / UDI-DI
- J021301900001
- Basic UDI-DI
- ++J021P0001PZ
- Direct Marketing DI
- +J021301900000
- FDA Product Code
- EFB
- EMDN Code
- Z12110180 Instruments for dental treatment units - hardware accessories
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.4200
- EU market of registration
- Austria
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
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