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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

(8012)V4.0.0 — Class I MDR by IMVITRO

MD Atlas
IMVITRO

EUDAMED last updated this device on Apr 24, 2023

(8012)V4.0.0

37700238583770023858038M5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IMVITRO
UDI-DI code: 03770023858038
Reference / catalog number: (8012)V4.0.0

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Manufacturer information

Organization name: IMVITRO
SRN: FR-MF-000013879
Manufacturer status: Active

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Oct 3, 2022	Jan 2, 2090
Spain	Oct 3, 2022	Jan 2, 2090

Device identification

Trade name: not provided
UDI-DI code: 03770023858038
Basic UDI-DI: 37700238583770023858038M5
Reference / catalog number: (8012)V4.0.0
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: Embryoly is a standalone software partly powered by Artificial Intelligence that assists In Vitro Fertilization (IVF) experts with their decision-making.
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

V637700238583770023858052LXOn 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.