Organization name

Pfizer Manufacturing Belgium NV

SRN

BE-MF-000003721

Manufacturer status

Active

Primary placement in Spain; available across 30 countries total.

Trade name

MiniQuick Shell

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.

15415062394851

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.

5415062PAA11934474

Reference / catalog number

PAA232964

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

The MiniQuick Shell is an optional device for use with the Genotropin MiniQuick. The device is for multiple-use and is reusable by a single patient (Mutiple use single patient device). The device is handheld.

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.

• A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.