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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

OVALE PM — Class I MDD by NAOMED

MD Atlas
NAOMED

EUDAMED last updated this device on Jul 12, 2022

OVALE PM

B-FR-MF-0000024232T

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NAOMED
UDI-DI code: D-FR-MF-0000024232T
Reference / catalog number: 2798433

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Manufacturer information

Organization name: NAOMED
SRN: FR-MF-000002423
Manufacturer status: Active

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: OVALE PM
UDI-DI code: D-FR-MF-0000024232T
Basic UDI-DI: B-FR-MF-0000024232T
Reference / catalog number: 2798433
Issuing entity: EUDAMED

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: Polyoléfine rigide capitonné . Orthèse vertébrale active lombaire d'élongation (Ovale) bivalve (module préfabriqué ne nécessitant pas de moulage), avec poche lombaire gonflable en polyuréthane.
Additional information URL: https://www.naomed.fr/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060308LUMBOSACRAL SPINE 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

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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.