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Sol Step™

by Brownmed, Inc.

Ref 50043Model X-Large, Large

Sol Step™ (50043) is a Class I device made by Brownmed, Inc., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 082161STSTSSXLG7U), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number082161STSTSSXLG7U Basic UDI-DI Date1 Jun 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
STEADY STEP® Sol Step™
Model / reference
X-Large, 50043, Large
Primary DI / UDI-DI
00821615004388, 00821615004210
Basic UDI-DI
082161STSTSSXLG7U, 082161STSTSSLGRQ
EMDN code
M0304010101 Elastic compression bandages, non-adhesive, low extensibility (<70%)
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008271
Authorised representative
AR Experts B.V. NL-AR-000023989

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Properties

Other properties (14, all answered No)