Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

STABIPOUCE AMBI — Class I MDR by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on Feb 12, 2024

STABIPOUCE AMBI

37014598POPIMM003STWE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459810673
Reference / catalog number: STABIPOUCE AMBI

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: GROUPE SOBER SAS
SRN: FR-MF-000017818
Manufacturer status: Active

Related devices

AMBI PLATEFORM37014598POIIMM031STRQOn the market ACCESSOIRE RIVETAGE LIBERTY37014598TECATM022STF5On the market CHEVILLE TECHNOCONCEPT37014598TECHCO005C17GOn the market CML CRYOSTAB37014598LOMCRY001STU2On the market CML CRYOSTAB37014598LOMCRY001STU2On 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.

CW018
Voir Précautions d'emploi & Méthode de pose

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: STABIPOUCE AMBI
UDI-DI code: 03701459810673
Basic UDI-DI: 37014598POPIMM003STWE
Reference / catalog number: STABIPOUCE AMBI
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: Trois baleinages : Doubles baleines en aluminium modelable stabilisant & soutenant efficacement le pouce et baleine thermoformée au niveau de la commissure. Le patient peut l’enfiler d’une seule main. Tissu type néoprène. Intérieur coton bouclette.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: UNIQUE - AMBIDEXTRE

EMDN nomenclature code(s)

Y060613WRIST-HAND-FINGERS ORTHOSES

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