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SmartPeg Type 025R
EUDAMEDClass I (EU MDR)
Ref 08086425Model Reusable SmartPeg
by Osstell AB
Identity
- Trade Name
- SmartPeg Type 025R EUDAMED
- Device Name
- SmartPeg EUDAMED
- Model / Reference
- Reusable SmartPeg EUDAMED08086425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09010522002803 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 025R 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 be06852c-6121-4c6b-a61c-1b11ecf7c2d2 61 fields · synced Aug 1, 2026