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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
- 06954454004975 EUDAMED
- Basic UDI-DI
- 69544540MITI001V2 EUDAMED
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
Category: Dental material mixing nozzle
Silicone rubber Mixing Tips by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental material mixing nozzle.
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- #1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
- Plasdent — PLASDENT CORP. · Class I
- Protemp™ Plus — 3M Deutschland GmbH · Class I
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 (1)
- EUDAMED 5490853a-2023-4e6c-81e1-e6ec956cb341 61 fields · synced Oct 9, 2026