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Orthosis, Foot (including Insoles And Inserts)
EUDAMEDClass I (EU MDR)
Ref K 09
Identity
- Device Name
- ORTHOSIS, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- Model / Reference
- K 09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903424137074 EUDAMED08903424137067 EUDAMED
- Basic UDI-DI
- 8903424OFI061203PJ EUDAMED
- Direct Marketing DI
- 08903424137074 EUDAMED08903424137067 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
Orthosis, Foot (including Insoles And Inserts) 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 (2)
- EUDAMED 679e34ac-8be9-4d13-b2f6-a8ea8f489e5a 61 fields · synced Jul 11, 2026
- EUDAMED f86d654d-0156-4428-ad25-70a9647a6ce2 61 fields · synced May 18, 2026