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SmartFlag by APOLLO
EUDAMEDClass I (EU MDR)
Ref 004.1S10.C-020-M48
by Apollo Implant Components Spółka Z Ograniczoną Odpowiedzialnością
Identity
- Trade Name
- SmartFlag by APOLLO EUDAMED
- Device Name
- Transfer Impression EUDAMED
- Model / Reference
- 004.1S10.C-020-M48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904890604513 EUDAMED
- Basic UDI-DI
- 59043474026RN EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
SmartFlag by APOLLO by Apollo Implant Components Spółka Z Ograniczoną Odpowiedzialnością — 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 | 59043474026RN | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000023711
Sources (1)
- EUDAMED 2c6d4e21-f718-4f39-ad2f-3d4d01d8f81d 61 fields · synced Jun 19, 2026