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Organization name
UDI-DI code
Reference / catalog number

MamaSafe 4 pairs — Class I MDR by MSP Medizintechnik GmbH

MD Atlas
MSP Medizintechnik GmbH

EUDAMED last updated this device on Aug 9, 2022

MamaSafe 4 pairs

912004788HSOMASANE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MSP Medizintechnik GmbH
UDI-DI code: 09120047882740
Reference / catalog number: HSOMASA4

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Manufacturer information

Organization name: MSP Medizintechnik GmbH
SRN: AT-MF-000018341
Manufacturer status: Inactive

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: MamaSafe 4 pairs
UDI-DI code: 09120047882740
Basic UDI-DI: 912004788HSOMASANE
Reference / catalog number: HSOMASA4
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 4
Additional product description: Die MamaSafe Brustwarzenschutzringe unterstützen den Heilungsprozess von wunden Brustwarzen – die durch das Stillen verursacht werden. MamaSafe schützt die Brustwarzen vor dem Verkleben mit der Kleidung und lässt die Luft ungehindert zirkulieren.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - 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

Related devices

HSOETT2010912004788HSOETTETOn the market HSOETT2000912004788HSOETTETOn the market HSO08912004788HSOFERSENFIXBUOn the market MamaSafe 20 pairs912004788HSOMASANEOn the market HSOOPFIX800912004788HSOOPFIX87On 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.