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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

003 IND — Class I MDR by INTEXTRED LTD.

MD Atlas
INTEXTRED LTD.

EUDAMED last updated this device on Oct 23, 2022

003 IND

3800600005866PP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INTEXTRED LTD.
UDI-DI code: 03800600005866
Reference / catalog number: 003 IND

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Manufacturer information

Organization name: INTEXTRED LTD.
SRN: BG-MF-000022519
Manufacturer status: Active

Market distribution

Primary placement in Bulgaria; available across 2 countries total.

Country	On market since	Until
BulgariaPrimary placement	Oct 29, 2021	Still on market
France	Oct 29, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03800600005866
Basic UDI-DI: 3800600005866PP
Reference / catalog number: 003 IND
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: 50
Additional product description: Surgical mask TypeIIR - Blue (5x10)
Additional information URL: No additional information URL provided by the manufacturer.
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

Related devices

002/20 IND3800600001813N6On the market 002/20 IND Black3800600005576PBOn 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.