Μ.BIRLI - A.TSITOURAS O.E.
GR-MF-000013450 · Greece · NEA SMIRNI
Μ.BIRLI - A.TSITOURAS O.E. is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 61 |
|---|
Most frequent device types declared: 3DYNAMIC AFO KIT STEP-ON 100/LH, 3DYNAMIC AFO KIT STEP-ON 100/MH, ACTIVE DYNAMIC FOOTPLATE 100/LH, ACTIVE DYNAMIC FOOTPLATE 100/MH, PP DYNAMIC AFO KIT STEP-ON 100/LH.
Devices declared under this manufacturer
- 3Dynamic AFO Kit 100 LH / Left / Large-Extra large
- 3Dynamic AFO Kit 100 LH / Left / Small- Medium
- Active Dynamic Footplate 100 LH / Left / Small-Medium
- Active Dynamic Footplate 100 LH / Right / Small-Medium
- Active Dynamic Footplate 100 MH / Left / Large-Extra large
- Active Dynamic Footplate Extension 100 MH / Left / Small-Medium
- Active Dynamic Footplate Extension 100 ΜH / Right / Small-Medium
- PP Dynamic AFO Kit 100 MH / Left / Small- Medium
- ΑΡΘΡΩΣΗ ΠΟΔΟΚΝΗΜΙΚΗΣ ΑΝΟΞΕΙΔΩΤΗ STEP-ON 100 / MEDIAL LEFT / LATERAL RI
- ΑΡΘΡΩΣΗ ΠΟΔΟΚΝΗΜΙΚΗΣ ΑΝΟΞΕΙΔΩΤΗ STEP-ON 100 / MEDIAL LEFT/LATERAL RIGH
- ΑΡΘΡΩΣΗ ΠΟΔΟΚΝΗΜΙΚΗΣ ΑΝΟΞΕΙΔΩΤΗ STEP-ON 100 LH / BAR 4 M.M. / CUFF / S
- ΚΝΗΜΟΠΟΔΙΚΟΣ ΚΗΔΕΜΟΝΑΣ Step-On AFO 100 LH/L-XL/R
Showing 12 of 61 declared devices.
Catalogue references include 3DAFO Kit/100LH/LT/S-M, FP/ 100LH/RT/S-M, FP/ 100MH/LT/L-XL, FP/ext./ 100MH/RT/S-M, Step-On AFO 200 DH/R/L, Step-On AFO 200 DH/R/S.
European nomenclature codes declared: Y06120602, Y061299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 61 |
| Country of registration | Greece |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 61 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Μ.BIRLI - A.TSITOURAS O.E. was not found in either the U.S. or the Canadian register.