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Stretch

by Brownmed, Inc. 2 variants

Ref 26921Model Adult Leg

Active European Union

CE MDR

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

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number082161STSTALAR Basic UDI-DI 00082161269212UDI-DIDate29 May 2026RegisteredStatusActive

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  • Withdrawn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
SEAL-TIGHT® Stretch
Model / Reference
Adult Leg, 26921
Primary DI / UDI-DI
00082161269212
Basic UDI-DI
082161STSTALAR
EMDN Code
M03030299 Protection systems - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

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

Related devices

Category: Cast/bandage waterproof bathing cover, reusable

Other devices from Brownmed, Inc.

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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