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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

10012 — Class I MDR by WERUNIA GmbH

MD Atlas
WERUNIA GmbH

EUDAMED last updated this device on Mar 18, 2025

10012

PP06830FP.53012303

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: WERUNIA GmbH
UDI-DI code: 111943475857
Reference / catalog number: 10012

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Manufacturer information

Organization name: WERUNIA GmbH
SRN: DE-MF-000007299
Manufacturer status: Active

Related devices

10005PP06830WP.53012359On the market 10024PP06830WP.53012359On the market 10007PP06830WP.53012359On the market 10033PP06830WP.53012359On the market 10032PP06830WP.53012359On 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.

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: 111943475857
Basic UDI-DI: PP06830FP.53012303
Reference / catalog number: 10012
Issuing entity: IFA

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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04010299FIXING DRESSINGS - 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

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Expiration date
Manufacturing date
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Software identification