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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

RESPI'SAC — Class I MDR by NATUR'ADEM

MD Atlas
NATUR'ADEM

EUDAMED last updated this device on Mar 24, 2025

RESPI'SAC

3770037841RESPISAC8M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NATUR'ADEM
UDI-DI code: 03770037841019
Reference / catalog number: RESPI'SAC

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Manufacturer information

Organization name: NATUR'ADEM
SRN: FR-MF-000046852
Manufacturer status: Active

Critical warnings

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

CW275
ask your doctor or pharmacist before use

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: RESPI'SAC
UDI-DI code: 03770037841019
Basic UDI-DI: 3770037841RESPISAC8M
Reference / catalog number: RESPI'SAC
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: Sac en papier kraft bio produit en France destiné aux personnes souffrant de crises d'angoisse et attaques de panique, dont l'usage consiste à respirer dedans pendant quelques minutes, jusqu'à la disparation des symptômes ( hyperventilation, palpitations, tremblements ..) sans excéder 10 minutes. Respirer dans ce sac permet de rééquilibrer les gaz et ainsi arrêter les symptômes liés à la crise.
Additional information URL: https://www.naturadem.com/
Clinical sizes: 23 MU10
16 MU10

EMDN nomenclature code(s)

R020199BREATHING CIRCUITS AND KITS - 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

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.