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Hy-Drop
EUDAMEDClass I (EU MDR)
Ref MW03Model MB01,MB02,MB03,MB04,DD01,DD02,DD030A,DD030B,SB01XL,SB01L,SB01M, SB01S,SB01SS,MW03,MW01,MW02,GD01
Identity
- Trade Name
- Hy-Drop 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 EUDAMEDMW03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001295 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
Hy-Drop 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 |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 934ba999-dd6d-4fbb-910b-8127efb2d693 61 fields · synced Oct 6, 2026