← Back to catalogue
Mixing Well
EUDAMEDClass I (EU MDR)
Ref /Model MB01,MB02,MB03,MB04,DD01,DD02,DD030A,DD030B,SB01XL,SB01L,SB01M, SB01S,SB01SS,MW03,MW01,MW02,GD01
Identity
- Trade Name
- Mixing Well EUDAMED
- Device Name
- Mixing Bowl EUDAMED
- Model / Reference
- MB01,MB02,MB03,MB04,DD01,DD02,DD030A,DD030B,SB01XL,SB01L,SB01M, SB01S,SB01SS,MW03,MW01,MW02,GD01 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001318 EUDAMED
- Basic UDI-DI
- 69544540MIBO001Q6 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
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
Mixing Well by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69544540MIBO001Q6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d29a62da-4214-4733-a8b9-824683a353b0 61 fields · synced Oct 8, 2026