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Disposable Micro Applicator
EUDAMEDClass I (EU MDR)
Ref 901Model 901, 902, 903, 904, 905,906
Identity
- Device Name
- Disposable Micro Applicator EUDAMED
- Model / Reference
- 901, 902, 903, 904, 905,906 EUDAMED901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975336240007 EUDAMED
- Basic UDI-DI
- 697533624RMA001KC EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE 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
Disposable Micro Applicator by Rocodent International Limited — 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 | 697533624RMA001KC | Class I | Active |
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Manufacturer
- Manufacturer
- Rocodent International Limited
- EUDAMED SRN
- CN-MF-000045441
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 78399833-03d0-4187-8e5a-4416dc8955e1 61 fields · synced Jul 30, 2026