Identity
- Trade Name
- Adhesive Tip Applicator EUDAMED
- Device Name
- Adhesive Tip Applicator EUDAMED
- Model / Reference
- SC08,SC08B,SC08C EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454006481 EUDAMED06954454005163 EUDAMED
- Basic UDI-DI
- 69544540ADTA001JV EUDAMED
- EMDN Code
- Q010506 PASTE APPLICATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Category: Dental material mixing nozzle
Adhesive Tip Applicator by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69544540ADTA001JV | 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 (2)
- EUDAMED 2e5b49a8-42a6-439e-a1a8-3d6304fe65d0 61 fields · synced Jul 14, 2026
- EUDAMED 076d5008-95f1-4779-87d6-30c69a688357 61 fields · synced May 19, 2026