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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

ERP877 — Class I MDR by NEWMEDI

MD Atlas
NEWMEDI

EUDAMED last updated this device on Nov 18, 2021

ERP877

37603019404995

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEWMEDI
UDI-DI code: 37603019404940
Reference / catalog number: ERP877

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Manufacturer information

Organization name: NEWMEDI
SRN: FR-MF-000000922
Manufacturer status: Active

Related devices

Nemwedi3760301940630VPOn the market Newmedi3760301940838WHOn the market Newmedi3760301944909NOn the market Newmedi3760301940524VPOn the market Newmedi3760301940876WROn 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.

Critical warnings

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

CW010
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: not provided
UDI-DI code: 37603019404940
Basic UDI-DI: 37603019404995
Reference / catalog number: ERP877
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: Free-Weights est une évolution dans les équipements de radioprotection. Il permet de protéger l’opérateur des rayons ionisants de part et d’autre (droite-face-gauche) de l’utilisateur offrant une protection optimale. Un vrai rempart contre les rayons X directs et diffusés, tout en lui libérant le corps du poids et des désagréments d’un équipement EPI (tablier chasuble et veste/jupes plombés).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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Expiration date
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Software identification