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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

7609005 — Class I MDD by Paul Albrechts Verlag…

MD Atlas
Paul Albrechts Verlag GmbH

EUDAMED last updated this device on Mar 11, 2022

7609005

B-04260724620014

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Paul Albrechts Verlag GmbH
UDI-DI code: 04260724620014
Reference / catalog number: 7609005

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Manufacturer information

Organization name: Paul Albrechts Verlag GmbH
SRN: DE-MF-000005333
Manufacturer status: Active

Critical warnings

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

CW011
Warnhinweise: • Der Schutz ist nur gegeben, wenn Mund und Nase vollständig bedeckt sind und eine sichere Befestigung gewährleistet ist • Die Maske muss umgehend gewechselt werden, wenn sie durchfeuchtet ist. • Der Träger darf den Maskenkörper nicht mit den Fingern/Händen berühren. Nach Ablegen ist eine vollständige Händedesinfektion durchzuführen.

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: 04260724620014
Basic UDI-DI: B-04260724620014
Reference / catalog number: 7609005
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Medizinischer Mund-Nasen-Schutz
Additional information URL: https://allpromed.de/allpromask-comfort
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

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

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.

Related devices

7609001B-04260724620007On the market