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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

61012 — Class I MDR by Alegro Medical GmbH

MD Atlas
Alegro Medical GmbH

EUDAMED last updated this device on Nov 24, 2022

61012

PP00597ALGCFV00142

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alegro Medical GmbH
UDI-DI code: 110364530639
Reference / catalog number: 61012

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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

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

CW133
:Do not use in case of known allergy to phenoxyethanol
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.

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: 110364530639
Basic UDI-DI: PP00597ALGCFV00142
Reference / catalog number: 61012
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 7 m bielastisch
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