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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

I00001 — Class IIb MDD by ECENTIAL ROBOTICS

MD Atlas
ECENTIAL ROBOTICS

EUDAMED last updated this device on Dec 10, 2021

I00001

B-03701311500407

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ECENTIAL ROBOTICS
UDI-DI code: 03701311500407
Reference / catalog number: I00001

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Manufacturer information

Organization name: ECENTIAL ROBOTICS
SRN: FR-MF-000003577
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 2 countries total.

Country	On market since	Until
FrancePrimary placement	Jun 28, 2017	May 26, 2024
Italy	Nov 14, 2019	May 26, 2024

Device identification

Trade name: not provided
UDI-DI code: 03701311500407
Basic UDI-DI: B-03701311500407
Reference / catalog number: I00001
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)

Z12130401STEREOTACTIC ORTHOPAEDIC SURGERY SYSTEMS

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

A00038B-03701311500391On the market A00019B-03701311500070On 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.