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Intral-Oral Tip
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
- Intral-Oral Tip 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
- 06954454001738 EUDAMED06954454001721 EUDAMED06954454001707 EUDAMED06954454001745 EUDAMED06954454001509 EUDAMED
- Basic UDI-DI
- 69544540MITI001V2 EUDAMED
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMEDBulgaria EUDAMEDAustria EUDAMEDFrance 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
Intral-Oral Tip 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 75e06fdd-339b-48ac-8518-d7eda6e695ac 61 fields · synced Oct 6, 2026
- EUDAMED 7e02df7c-4d15-4f1e-9c66-12c55bbf6060 61 fields · synced May 17, 2026
- EUDAMED 9dbd9bdf-5daf-4af1-a50e-5fc6ad9ab3b7 61 fields · synced May 17, 2026
- EUDAMED 41f67fa3-8d19-4827-aa2a-914ad6ec6556 61 fields · synced May 18, 2026
- EUDAMED f2b24ba9-98f8-4224-9668-26f2153e8868 61 fields · synced May 19, 2026