Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

0003 - 005 — Class I MDR by Univent Medical GmbH

MD Atlas
Univent Medical GmbH

EUDAMED last updated this device on Mar 26, 2026

0003 - 005

426068838000X43

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Univent Medical GmbH
UDI-DI code: 04260688382133
Reference / catalog number: 0003 - 005

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Univent Medical GmbH
SRN: DE-MF-000015594
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04260688382133
Basic UDI-DI: 426068838000X43
Reference / catalog number: 0003 - 005
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Dual-use Atemschutzmaske - Medizinische Gesichtsmaske TypIIR und FFP2 Maske
Additional information URL: https://www.univent-medical.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

4002 - 006426068838400X4XOn the market 4003 - 006426068838400X4XOn the market 4004 - 006426068838400X4XOn the market 2102 - 011426068838200125On the market 2103426068838200125On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.