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SmartPeg Type 026R
EUDAMEDClass I (EU MDR)
Ref 08086426Model Reusable SmartPeg
by Osstell AB
Identity
- Trade Name
- SmartPeg Type 026R EUDAMED
- Device Name
- SmartPeg EUDAMED
- Model / Reference
- Reusable SmartPeg EUDAMED08086426 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09010522002810 EUDAMED
- Basic UDI-DI
- 9010522SmartPegsRFX EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
SmartPeg Type 026R by Osstell AB — 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 | 9010522SmartPegsRFX | Class I | Active |
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Manufacturer
- Manufacturer
- Osstell AB
- EUDAMED SRN
- SE-MF-000002162
Sources (1)
- EUDAMED a17aa2ea-685b-4944-b473-11a162ac7d2d 61 fields · synced Jul 9, 2026