Bur Holder Frame
by Huanghua Promisee Dental Co.Ltd.
Ref BF01Model BB01,BB02,BB03,BB09,BC01,BF01,BF06
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69544540BUHB001NE 06954454000595 | Date17 Mar 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Bur Holder Box
- Model / reference
- BB01, BB02, BB03, BB09, BC01, BF01, BF06
- Primary DI / UDI-DI
- 06954454000595
- Basic UDI-DI
- 69544540BUHB001NE
- EMDN code
- Q0199 Odontology devices - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000014766
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Huanghua Promisee Dental Co.Ltd.
Properties
Other properties (13)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No