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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

STABINECK C1 — Class I MDD by GROUPE SOBER SAS

MD Atlas
GROUPE SOBER SAS

EUDAMED last updated this device on May 16, 2023

STABINECK C1

B-03701459800650

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: GROUPE SOBER SAS
UDI-DI code: 03701459800650
Reference / catalog number: STABINECK C1

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Manufacturer information

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

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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.

Critical warnings

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

CW018
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: not provided
UDI-DI code: 03701459800650
Basic UDI-DI: B-03701459800650
Reference / catalog number: STABINECK C1
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: One-piece cervical collar for lightweight cervical spine support. Comfort of chin and neck supports. Self-gripping back closure. Comes with an extra protective jersey for hygiene. Model available in 5 sizes. Color-coded by size
Additional information URL: https://www.sober.fr/produit/stabineck-c1/
Clinical sizes: TS - Hauteur : 8cm - Tour de cou : 29 à 32 cm

EMDN nomenclature code(s)

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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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