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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

22001 — Class I MDR by Alegro Medical GmbH

MD Atlas
Alegro Medical GmbH

EUDAMED last updated this device on Feb 23, 2023

22001

PP00597ALGCFV00630

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alegro Medical GmbH
UDI-DI code: 110217376261
Reference / catalog number: 22001

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Manufacturer information

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

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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.

CW133
Do not apply directly on wounds.

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: 110217376261
Basic UDI-DI: PP00597ALGCFV00630
Reference / catalog number: 22001
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: 10 cm x 10 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
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Software identification