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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

Blouse de Protection enfant bleu… — Class I MDR by AMBITION

MD Atlas
AMBITION

EUDAMED last updated this device on Apr 4, 2023

Blouse de Protection enfant bleu / rose polypropylène Français 25 g

3770023808BBE/BREXN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AMBITION
UDI-DI code: 03770023808132
Reference / catalog number: BBE/BRE

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Manufacturer information

Organization name: AMBITION
SRN: FR-MF-000034559
Manufacturer status: Active

Critical warnings

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

CW010
Voir notice d'utilisation

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: Blouse de Protection enfant bleu / rose polypropylène Français 25 g
UDI-DI code: 03770023808132
Basic UDI-DI: 3770023808BBE/BREXN
Reference / catalog number: BBE/BRE
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: La blouse de protection est un vêtement à usage unique offrant sécurité et protection aux enfants. Blouse confectionnée en France dans nos ateliers. Fiche technique :- Toile non tissée- 100 % Polypropylène - Poids : 25 g/m²- Non stérile- Assemblage, finition surjet de propreté- Lien noué à la taille et à l'encolure- Manches longues avec poignets élastiqués- Taille unique- Coloris : Bleu ou rose Instructions de stockage- Stocker dans l'emballage d'origine à l'abri de la lumière et de l'humidité
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0205NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

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.