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

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Organization name
UDI-DI code
Reference / catalog number

EST 00300 — Class I MDR by EST biochem GmbH

MD Atlas
EST biochem GmbH

EUDAMED last updated this device on Oct 25, 2024

EST 00300

426247188ESTBIOCHEMDM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EST biochem GmbH
UDI-DI code: 04262471880031
Reference / catalog number: EST 00300

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Manufacturer information

Organization name: EST biochem GmbH
SRN: DE-MF-000041293
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jun 30, 2024	Dec 30, 2025
Denmark	Jun 30, 2024	Dec 30, 2025

Device identification

Trade name: not provided
UDI-DI code: 04262471880031
Basic UDI-DI: 426247188ESTBIOCHEMDM
Reference / catalog number: EST 00300
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: Skin first aid decontamination spray for chemical accidents
Additional information URL: https://www.est-biochem.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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

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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.