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Micro Applicator
EUDAMEDClass I (EU MDR)
Ref /Model MA01,MA01F,MA01SF,MA01R,MA01K,MA02,MA02R,MA02F,MA02SF,MA02K,MA03,MA03R,MA03F,MA03SF,MA03K,MA06,MA06R,MA06F,MA06SF,MA06K,MA07,MA07R,MA07F,MA07SF,MA07K,MA08,DYMA01R,DYMA01F,DYMA01SF,DYMA02R,DYMA02F,DYMA02SF,DYMA03R,DYMA03F,DYMA03SF,DYMA04R,DYMA04F,DYMA04SF
Identity
- Trade Name
- Micro Applicator EUDAMED
- Device Name
- Micro Applicator EUDAMED
- Model / Reference
- MA01,MA01F,MA01SF,MA01R,MA01K,MA02,MA02R,MA02F,MA02SF,MA02K,MA03,MA03R,MA03F,MA03SF,MA03K,MA06,MA06R,MA06F,MA06SF,MA06K,MA07,MA07R,MA07F,MA07SF,MA07K,MA08,DYMA01R,DYMA01F,DYMA01SF,DYMA02R,DYMA02F,DYMA02SF,DYMA03R,DYMA03F,DYMA03SF,DYMA04R,DYMA04F,DYMA04SF EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454004005 EUDAMED
- Basic UDI-DI
- 69544540MIAP001Q2 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental material injection cannula, single-use
Micro 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 | 69544540MIAP001Q2 | 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 715b4459-6007-45e0-a632-10889a211ce0 61 fields · synced Jun 18, 2026