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Hot/Cold Sleeve

by Brownmed, Inc. 2 variants

Ref 31615Model Small/Medium

Hot/Cold Sleeve (31615) is a Class I device made by Brownmed, Inc., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 082161PISLVA9), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number082161PISLVA9 Basic UDI-DI 00082161316152UDI-DIDate28 May 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  • Withdrawn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™ Hot/Cold Sleeve
Model / reference
Small/Medium, 31615
Primary DI / UDI-DI
00082161316152
Basic UDI-DI
082161PISLVA9
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

Related devices

Category: Hot/cold therapy pack, reusable

Similar devices in this category

Other devices filed under CRYOTHERAPY AND THERMOTHERAPY DEVICES.

Other devices from Brownmed, Inc.

See all devices from Brownmed, Inc. →

Properties

Other properties (14, all answered No)