Identity
- Trade Name
- TYNOR EUDAMED
- Device Name
- ORTHOSIS, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Model / Reference
- K 09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903424739087 EUDAMED
- Basic UDI-DI
- 8903424OFI061203PJ EUDAMED
- Direct Marketing DI
- 08903424739087 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Tynor Orthotics Pvt Ltd is a medical device directory's trusted resource for finding accurate and up-to-date information on orthotic devices, including implants, inserts, soles, and more. Our comprehensive database features detailed product information, companion diagnostics, and compliance data, making it easy to locate the perfect fit for your specific needs.
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 | 8903424OFI061203PJ | Class I | Active |
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Manufacturer
- Manufacturer
- Tynor Orthotics Pvt Ltd
- EUDAMED SRN
- IN-MF-000005705
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 6161e28a-60bc-4211-89d3-07d6237bdb42 61 fields · synced Jul 20, 2026