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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

ASK4MASK Medical face mask — Class I MDR by SC EURO IMPACT SRL

MD Atlas
SC EURO IMPACT SRL

EUDAMED last updated this device on Jul 13, 2022

ASK4MASK Medical face mask

59447590475944759047EIFF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SC EURO IMPACT SRL
UDI-DI code: 05944759047013
Reference / catalog number: ASK4MASK-5-ALBASTRU

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View device family (Basic UDI)

Manufacturer information

Organization name: SC EURO IMPACT SRL
SRN: RO-MF-000021106
Manufacturer status: Active

Critical warnings

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

CW010
The box has the symbol to see the instructions for use which are mentioned on the packaging.

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Market distribution

Primary placement in Romania; available across 1 country total.

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

Device identification

Trade name: ASK4MASK Medical face mask
UDI-DI code: 05944759047013
Basic UDI-DI: 59447590475944759047EIFF
Reference / catalog number: ASK4MASK-5-ALBASTRU
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: 1
Additional product description: ASK4MASK medical face mask, type IIR, blue colour is intended to limit the transmission of infectious agent (viruses, bacteria, fungous) from medical staff to the pacient, during surgical procedures and other medical areas with similar requirements. The product is 175*95 mm, has 3 layers and 3 plies and is packed in boxes with 5pcs/box.
Additional information URL: http://ask4mask.ro/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944759047013

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

T0399PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - 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

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Related devices

ASK4MASK Medical face mask59447590475944759047ROZ6DOn the market ASK4MSK Medical face mask5944759047ASK4MASKEINGOn 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.