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SmartFlag by APOLLO
EUDAMEDClass I (EU MDR)
Ref 004.2S5.G-013-M45
by Apollo Implant Components Spółka Z Ograniczoną Odpowiedzialnością
Identity
- Trade Name
- SmartFlag by APOLLO EUDAMED
- Device Name
- Transfer Impression EUDAMED
- Model / Reference
- 004.2S5.G-013-M45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904890604872 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
Category: Dental implant suprastructure, temporary, preformed, single-use
SmartFlag by APOLLO by Apollo Implant Components Spółka Z Ograniczoną Odpowiedzialnością — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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 8b6f8ae8-7086-40ce-a17e-aacc64622803 61 fields · synced Jun 18, 2026