Eye Cuff closed single-patient use

Organization name

HILOTHERM GmbH

SRN

DE-MF-000006176

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW262

  Each cuff may only be used on one patient
• CW010

  Die Gebrauchsanweisung der Hilotherm Geräte muss beachtet werden.
• CW999

  Apply only to intact skin
• CW999

  Check for leaks before each application

Primary placement in Germany; available across 32 countries total.

Trade name

Eye Cuff closed single-patient use

UDI-DI code

04250387100466

Basic UDI-DI

42503871MANEMFP

Reference / catalog number

15000002

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 22–24 MU10
• 9–10 MU10

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification