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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

338266 — Class I MDD by Merckle GmbH

MD Atlas
Merckle GmbH

EUDAMED last updated this device on Nov 10, 2025

338266

B-338266PX

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Merckle GmbH
UDI-DI code: D-338266PX
Reference / catalog number: 338266

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Manufacturer information

Organization name: Merckle GmbH
SRN: DE-MF-000018230
Manufacturer status: Active

Critical warnings

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

CW999
Do not use on broken or injured skin
CW999
For external use only.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Jul 3, 2017	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-338266PX
Basic UDI-DI: B-338266PX
Reference / catalog number: 338266
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Additional catalogue numbers : 328334 , 338289 , 338288
Additional information URL: No additional information URL provided by the manufacturer.
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.