Organization name

HIDROFER SA

SRN

PT-MF-000002824

Manufacturer status

Active

Primary placement in Estonia; available across 32 countries total.

Trade name

HYDROPHILIC COTTON PLEATS

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.

05607324372018

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-05607324372018

Reference / catalog number

401-050 KAIGERT

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

BAG WITH 50 GR OF HYDROPHILIC COTTON WOOL PLEATS

Additional information URL

https://www.hidrofer.com/

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.

• M010101HYDROPHILIC COTTON

• Class I medical devices in EUDAMED

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