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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

56003 — Class I MDR by Alegro Medical GmbH

MD Atlas
Alegro Medical GmbH

EUDAMED last updated this device on Nov 28, 2022

56003

PP00597ALGCFV00513

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alegro Medical GmbH
UDI-DI code: 110537533127
Reference / catalog number: 56003

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Manufacturer information

Organization name: Alegro Medical GmbH
SRN: DE-MF-000026024
Manufacturer status: Active

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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.

Critical warnings

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

CW129
Should not be used in phlebitis (septic phlebitis), deep vein thrombosis (phlegmasia coeruela dolens), in heart failure or over superinfected wounds. In case of ulcus cruris with arterial component, the valid rules must be observed.
CW133
Do not use in case of known allergy to phenoxyethanol.For large-area application in children under 2 years of age, body temperature should be checked every half hour (until the 3rd hour after application of the bandage). If the body temperature drops systemically by 1 °C and the bandage is still moist, it should be removed.

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: 110537533127
Basic UDI-DI: PP00597ALGCFV00513
Reference / catalog number: 56003
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: 10
Additional product description: 8 cm x 3 m längselastisch
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M03020299MEDICATED BANDAGES, WITH ZINC OXIDE AND OTHER COMPONENTS - 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
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Software identification