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Organization name
UDI-DI code
Reference / catalog number

Masques chir. IIR élastiques bleu — Class I MDR by MEDISTAR

MD Atlas
MEDISTAR

EUDAMED last updated this device on Apr 3, 2025

Masques chir. IIR élastiques bleu

3665502PROTEC3X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDISTAR
UDI-DI code: 03665502006256
Reference / catalog number: 7015R

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Manufacturer information

Organization name: MEDISTAR
SRN: FR-MF-000042737
Manufacturer status: Active

Critical warnings

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

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

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: Masques chir. IIR élastiques bleu
UDI-DI code: 03665502006256
Basic UDI-DI: 3665502PROTEC3X
Reference / catalog number: 7015R
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: —
Additional information URL: https://medistar.fr/produit/masques-bleu-chir-iir-elastiques/
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

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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.