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SmartPeg Type 127 MegaGen
EUDAMEDClass I (EU MDR)
Ref 100810Model Single-use SmartPeg
by Osstell AB
Identity
- Trade Name
- SmartPeg Type 127 MegaGen EUDAMED
- Device Name
- SmartPeg EUDAMED
- Model / Reference
- Single-use SmartPeg EUDAMED100810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09010522002513 EUDAMED
- Basic UDI-DI
- 9010522SmartPegsBP EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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 127 MegaGen 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 | 9010522SmartPegsBP | Class I | Active |
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Manufacturer
- Manufacturer
- Osstell AB
- EUDAMED SRN
- SE-MF-000002162
Sources (1)
- EUDAMED e24b9d96-dc38-4fdf-87b8-7fdc2cef1376 61 fields · synced Aug 4, 2026