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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

34558 — Class I MDR by Alegro Medical GmbH

MD Atlas
Alegro Medical GmbH

EUDAMED last updated this device on Feb 24, 2023

34558

PP00597ALGCFV00747

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alegro Medical GmbH
UDI-DI code: 111867391751
Reference / catalog number: 34558

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Manufacturer information

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

Related devices

60211PP00597ALGCFV00142On the market 60213PP00597ALGCFV00142On the market 60212PP00597ALGCFV00142On the market 60007PP00597ALGCFV00142On the market 60005PP00597ALGCFV00142On 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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW129
EUH208:Should not be used in peripheral arterial occlusive disease, decompensated heart failure, septic phlebitis, phlegmasia coerulea dolens,on diabetic patients with advanced vessel disease.

Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 111867391751
Basic UDI-DI: PP00597ALGCFV00747
Reference / catalog number: 34558
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 6 m
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
Serial number
Software identification