Identity
- Trade Name
- TYNOR EUDAMED
- Device Name
- ORTHOSIS, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Model / Reference
- K 01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903424133052 EUDAMED
- Basic UDI-DI
- 8903424OFI061203PJ EUDAMED
- Direct Marketing DI
- 08903424133052 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Tynor by Tynor Orthotics Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 47c01e11-894d-4218-b070-0dc39b8f5c2a 61 fields · synced Jun 20, 2026