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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

DELTEX — Class IIb MDD by DELTEX

MD Atlas
DELTEX

EUDAMED last updated this device on Jun 14, 2023

DELTEX

B-03701475108549

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: DELTEX
UDI-DI code: 03701475108549
Reference / catalog number: 2901604

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Manufacturer information

Organization name: DELTEX
SRN: FR-MF-000002872
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Jan 1, 2008	May 26, 2024

Device identification

Trade name: DELTEX
UDI-DI code: 03701475108549
Basic UDI-DI: B-03701475108549
Reference / catalog number: 2901604
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P0199PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL – OTHERS

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

DELTEXB-03701475106231On the market DELTEXB-03701475106569On the market DELTEXB-03701475106330On the market DELTEXB-03701475107856On the market DELTEXB-03701475107870On 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.