← Back to catalogue
Silicone Small Bowl
EUDAMEDClass I (EU MDR)
Ref SB01MModel MB01,MB02,MB03,MB04,DD01,DD02,DD030A,DD030B,SB01XL,SB01L,SB01M, SB01S,SB01SS,MW03,MW01,MW02,GD01
Identity
- Trade Name
- Silicone Small Bowl 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 EUDAMEDSB01M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000670 EUDAMED
- Basic UDI-DI
- 69544540MIBO001Q6 EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Silicone Small Bowl 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 ea8496a3-30f4-4905-85ed-fb2949e878be 61 fields · synced Oct 7, 2026