Pneumatic Short Walking Boot

by BioSkin LLC EUDAMED

Active European Union

Ref 33034, 33031, 33030Model 3303

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0810094433303QN Basic UDI-DI	Date9 Aug 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference: 3303, 33034, 33031, 33030

Primary DI / UDI-DI: 00810094433284, 00810094433253, 00810094433246
Basic UDI-DI: 0810094433303QN
EMDN Code: Y06120601 Passive ankle-foot orthoses

Device Class: Class I
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: US-MF-000016322
Authorised representative: Rollerwerk Medical Engineering & Consulting DE-AR-000015883

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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