Organization name

DeRoyal Industries, Inc.

SRN

US-MF-000002102

Manufacturer status

Active

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

• Caution
• Do not re-use
• Consult instructions for use
• Do not use if package is damaged
• MR UNSAFE

Primary placement in Netherlands; available across 32 countries total.

Trade name

HYDRO-TEMP Cover without Foam

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00749756166317

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-00749756166317

Reference / catalog number

HNICU-02

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

HYDRO-TEMP Cover without Foam

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V03010299BODY TEMPERATURE MONITORING PROBES - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.