Identity
- Trade Name
- Sectra Orthopaedic Package 19.2 EUDAMED
- Device Name
- Sectra Orthopaedic Package EUDAMED
- Model / Reference
- 121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350092810678 EUDAMED
- Basic UDI-DI
- 735009281Orthopedic_App84 EUDAMED
- Direct Marketing DI
- 07350092810678 EUDAMED
- EMDN Code
- Z12139092 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sectra Orthopaedic Package 19.2 by Sectra AB — Class IIa — 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 | 735009281Orthopedic_App84 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sectra AB
- EUDAMED SRN
- SE-MF-000008882
Sources (1)
- EUDAMED 87ce6bec-84a8-4b21-bce0-743fa8479a63 61 fields · synced Jun 18, 2026