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Silicone rubber Mixing Tips
EUDAMEDClass I (EU MDR)
Ref /Model HP01,HP02,HP03,HP03A,HP03B, HP03C,HP04,HP05,HP06,HP07,HP08,HP09,HP10,IOT01,IOT02,IOT03,IOT04,IOT05,IOT06,QI07
Identity
- Trade Name
- Silicone rubber Mixing Tips EUDAMED
- Device Name
- Silicone rubber Mixing Tips EUDAMED
- Model / Reference
- HP01,HP02,HP03,HP03A,HP03B, HP03C,HP04,HP05,HP06,HP07,HP08,HP09,HP10,IOT01,IOT02,IOT03,IOT04,IOT05,IOT06,QI07 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001684 EUDAMED06954454000113 EUDAMED06954454000069 EUDAMED06954454000106 EUDAMED06954454001691 EUDAMED
- Basic UDI-DI
- 69544540MITI001V2 EUDAMED
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMEDDenmark EUDAMEDFrance EUDAMEDBelgium EUDAMEDCyprus 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
Silicone rubber Mixing Tips 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 | 69544540MITI001V2 | 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 (5)
- EUDAMED 714a1360-ce3d-4cb5-a326-f5e4f2323777 61 fields · synced Oct 7, 2026
- EUDAMED d76086c8-20a6-4f61-aadf-1eab857576a7 61 fields · synced May 16, 2026
- EUDAMED 4685851b-5c60-41e8-bf4b-d3fcfd2841bf 61 fields · synced May 17, 2026
- EUDAMED 62094116-c3ce-4205-9224-af996083b2a9 61 fields · synced May 17, 2026
- EUDAMED d85547cf-8175-468e-9a09-7ed1b03659e2 61 fields · synced May 18, 2026