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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

10018000/R — Class I MDR by Poirot Plastique…

MD Atlas
Poirot Plastique Industrie Médical

EUDAMED last updated this device on Jan 22, 2025

10018000/R

37603129910018000OBCB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Poirot Plastique Industrie Médical
UDI-DI code: 03760312990372
Reference / catalog number: 10018000/R

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Manufacturer information

Organization name: Poirot Plastique Industrie Médical
SRN: FR-MF-000023833
Manufacturer status: Active

Critical warnings

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

CW010
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: not provided
UDI-DI code: 03760312990372
Basic UDI-DI: 37603129910018000OBCB
Reference / catalog number: 10018000/R
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: le Guard est utilisé pour maintenir la bouche du patient ouverte et permettre le passage d’un endoscope. Il garantit également la protection de la gaine de l’endoscope contre d’éventuelles morsures du patient
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G0380DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES

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

1001801137603129910018000OBCBOn the market 1001800037603129910018000OBCBOn the market 10018000537603129910018000OBCBOn the market AN236000037603129910018000OBCBOn the market 1-guard plus mini37603129910018000OBCBOn 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.