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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

ERA MEDICAL — Class I MDR by NEW STYLE

MD Atlas
NEW STYLE

EUDAMED last updated this device on Mar 31, 2022

ERA MEDICAL

3800910107705J

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEW STYLE
UDI-DI code: 03800910107755
Reference / catalog number: 10770

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Manufacturer information

Organization name: NEW STYLE
SRN: BG-MF-000022200
Manufacturer status: Active

Market distribution

Primary placement in Bulgaria; available across 2 countries total.

Country	On market since	Until
BulgariaPrimary placement	Mar 1, 2020	Still on market
France	May 21, 2020	Still on market

Device identification

Trade name: ERA MEDICAL
UDI-DI code: 03800910107755
Basic UDI-DI: 3800910107705J
Reference / catalog number: 10770
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, Type IIR for kids - blue
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

138009101073158On the market 638009101071152On the market 33800910107855XOn the market 23800910107155AOn the market 83800910107615HOn 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.