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Omni Wrap

by Brownmed, Inc.

Ref 30150Model One Size

Omni Wrap (30150) is a Class I device made by Brownmed, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 082161OMNWRAS), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number082161OMNWRAS Basic UDI-DI 00082161301509UDI-DIDate6 Nov 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  • Withdrawn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
Polar Ice™ Omni Wrap
Model / reference
One Size, 30150
Primary DI / UDI-DI
00082161301509
Basic UDI-DI
082161OMNWRAS
EMDN code
M9001 Cryotherapy and thermotherapy devices
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)