Organization name

Jumar Corporation

SRN

US-MF-000013682

Manufacturer status

Active

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

• Consult instructions for use
• Single patient multiple use
• P332 – If skin irritation occurs: P322 – Specific measures (see on this label).

  If irritation occurs, discontinue use immediately

• Caution

  Do not use the Aqualizer if you lack a normal gag reflex

Primary placement in Germany; available across 32 countries total.

Trade name

Aqualizer

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.

00860013921101

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.

++D076AQUALIZER30001UW

Reference / catalog number

AQ-100

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

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

Status

On the market

Quantity

1

Additional product description

Hydrostatic occlusal splint, Aqualizer assembly, Ultra Medium

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.

• Q01020605TEMPORARY DENTAL PROSTHESES

• Class I medical devices in EUDAMED

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