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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

DEEPZEN 2D — Class I MDR by Deepsen

MD Atlas
Deepsen

EUDAMED last updated this device on Mar 5, 2025

DEEPZEN 2D

3770020227DEEPSEN2DW9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Deepsen
UDI-DI code: 03770020227073
Reference / catalog number: AP1

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Manufacturer information

Organization name: Deepsen
SRN: FR-MF-000037103
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: DEEPZEN 2D
UDI-DI code: 03770020227073
Basic UDI-DI: 3770020227DEEPSEN2DW9
Reference / catalog number: AP1
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: DEEPZEN 2D consist in DEEPSEN 2D V1.X.Y medical device, a Xreal glasses AR Air 2 Pro, Xreal smartphone Beam Pro, JBL headset Tune 710BT, a cover set and a headband
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

DEEPSEN3770020227DEEPSEN3JOn the market DEEPSEN3770020227DEEPSEN3JOn the market DEEPSEN 2D3770020227DEEPSEN2DW9On the market DEEPZEN 2D3770020227DEEPSEN2DW9On 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.