Ortopedická obuv pre diabetikov

Ref AF16392, AF17392, AM19371, M18463, AM18452, AM19461, AF16391, AF17402, AM18432, AM18402, AM18411, AF16393, AM19363, AM19472, AM19433, AM19391, AM19432, AF16401, AM18401, AF16383, AF16402, AF17421, AM19413, AM19401, AF16372, AM18442, AM18412, AF16371, AM19382, AF16363, AM19462, TM24373, A16362, AM30361, AF17362, TM24372, AM18453, AF16381, AM19393, AF17363, AF17383, AM19361, AM18422, AM19451, AM19402, AM18403, AM18433, AM18462, AF16382, AM18471Model midnight tulip 39 wide, cloudy orchid 39 wide, refreshing black 37 medium, morning blue 46 extra wide, morning blue 45 wide, refreshing black 46 medium, midnight tulip 39 medium, cloudy orchid 40 wide, morning blue 43 wide, morning blue 40 wide, morning blue 41 medium, midnight tulip 39 extra wide, refreshing black 36 extra wide, refreshing black 47 wide, refreshing black 43 extra wide, refreshing black 39 medium, refreshing black 43 wide, midnight tulip 40 medium, morning blue 40 medium, midnight tulip 38 extra wide, midnight tulip 40 wide, cloudy orchid 42 medium, refreshing black 41 extra wide, refreshing black 40 medium, midnight tulip 37 wide, morning blue 44 wide, morning blue 41 wide, midnight tulip 37 medium, refreshing black 38 wide, midnight tulip 36 extra wide, refreshing black 46 wide, black coffe 37 extra wide, midnight tulip 36 wide, Smooth Jazz 36 medium, cloudy orchid 36 wide, black coffee 37 wide, morning blue 45 extra wide, midnight tulip 38 medium, refreshing black 39 extra wide, cloudy orchid 36 extra wide, cloudy orchid 38 extra wide, refreshing black 36 medium, morning blue 42 wide, refreshing black 45 medium, refreshing black 40 wide, morning blue 40 extra wide, morning blue 43 extra wide, morning blue 46 wide, midnight tulip 38 wide, morning blue 47 medium

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	NumberB-04260502823033 Basic UDI-DI	Date10 Jul 2024Registered	StatusActive
European Union	CE/MDD	NumberB-04260502823033 Basic UDI-DI	Date10 Jul 2024Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device Name: Ortopedická obuv pre diabetikov
Model / Reference: midnight tulip 39 wide, AF16392, cloudy orchid 39 wide, AF17392, refreshing black 37 medium, AM19371, morning blue 46 extra wide, M18463, morning blue 45 wide, AM18452, refreshing black 46 medium, AM19461, midnight tulip 39 medium, AF16391, cloudy orchid 40 wide, AF17402, morning blue 43 wide, AM18432, morning blue 40 wide, AM18402, morning blue 41 medium, AM18411, midnight tulip 39 extra wide, AF16393, refreshing black 36 extra wide, AM19363, refreshing black 47 wide, AM19472, refreshing black 43 extra wide, AM19433, refreshing black 39 medium, AM19391, refreshing black 43 wide, AM19432, midnight tulip 40 medium, AF16401, morning blue 40 medium, AM18401, midnight tulip 38 extra wide, AF16383, midnight tulip 40 wide, AF16402, cloudy orchid 42 medium, AF17421, refreshing black 41 extra wide, AM19413, refreshing black 40 medium, AM19401, midnight tulip 37 wide, AF16372, morning blue 44 wide, AM18442, morning blue 41 wide, AM18412, midnight tulip 37 medium, AF16371, refreshing black 38 wide, AM19382, midnight tulip 36 extra wide, AF16363, refreshing black 46 wide, AM19462, black coffe 37 extra wide, TM24373, midnight tulip 36 wide, A16362, Smooth Jazz 36 medium, AM30361, cloudy orchid 36 wide, AF17362, black coffee 37 wide, TM24372, morning blue 45 extra wide, AM18453, midnight tulip 38 medium, AF16381, refreshing black 39 extra wide, AM19393, cloudy orchid 36 extra wide, AF17363, cloudy orchid 38 extra wide, AF17383, refreshing black 36 medium, AM19361, morning blue 42 wide, AM18422, refreshing black 45 medium, AM19451, refreshing black 40 wide, AM19402, morning blue 40 extra wide, AM18403, morning blue 43 extra wide, AM18433, morning blue 46 wide, AM18462, midnight tulip 38 wide, AF16382, morning blue 47 medium, AM18471

Primary DI / UDI-DI: 04260502823033, 04260502821091, 04260502823620, 04260502823583, 04260502823545, 04260502823897, 04260502823026, 04260502821121, 04260502823484, 04260502823392, 04260502823415, 04260502823040, 04260502823613, 04260502825013, 04260502823828, 04260502823682, 04260502823811, 04260502823057, 04260502823385, 04260502823019, 04260502823064, 04260502821176, 04260502823767, 04260502823712, 04260502822975, 04260502823514, 04260502823422, 04260502822968, 04260502823668, 04260502822951, 04260502823903, 08586022881763, 04260502822944, 08586022882784, 04260502821008, 08586022881756, 04260502823552, 04260502822999, 04260502823705, 04260502821015, 04260502821077, 04260502823590, 04260502823453, 04260502823866, 04260502823729, 04260502823408, 04260502823491, 04260502823576, 04260502823002, 04260502825020
Basic UDI-DI: B-04260502823033, B-04260502821091, B-04260502823620, B-04260502823583, B-04260502823545, B-04260502823897, B-04260502823026, B-04260502821121, B-04260502823484, B-04260502823392, B-04260502823415, B-04260502823040, B-04260502823613, B-04260502825013, B-04260502823828, B-04260502823682, B-04260502823811, B-04260502823057, B-04260502823385, B-04260502823019, B-04260502823064, B-04260502821176, B-04260502823767, B-04260502823712, B-04260502822975, B-04260502823514, B-04260502823422, B-04260502822968, B-04260502823668, B-04260502822951, B-04260502823903, B-08586022881763, B-04260502822944, 0858602288AM30361YQ, B-04260502821008, B-08586022881756, B-04260502823552, B-04260502822999, B-04260502823705, B-04260502821015, B-04260502821077, B-04260502823590, B-04260502823453, B-04260502823866, B-04260502823729, B-04260502823408, B-04260502823491, B-04260502823576, B-04260502823002, B-04260502825020
EMDN Code: Y063303 Ready-made orthotic shoes

Device Class: Class I
EU market of registration: Slovakia
Czechia

Manufacturer details

EUDAMED SRN: DE-MF-000040108

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Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No