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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

directSTIM External Pulse Generator — AIMDD AIMDD

MD Atlas
Aleva Neurotherapeutics SA

EUDAMED last updated this device on Nov 19, 2021

directSTIM External Pulse Generator

B-07640183760068

On the marketAIMDD

Applicable legislation: AIMDD [Directive 90/385/EEC on active implantable medical devices]
Organization name: Aleva Neurotherapeutics SA
UDI-DI code: 07640183760068
Reference / catalog number: 12400

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Manufacturer information

Organization name: Aleva Neurotherapeutics SA
SRN: CH-MF-000015804
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW027
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: directSTIM External Pulse Generator
UDI-DI code: 07640183760068
Basic UDI-DI: B-07640183760068
Reference / catalog number: 12400
Issuing entity: GS1

Classification

Risk category: AIMDD
Applicable legislation: AIMDD [Directive 90/385/EEC on active implantable 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)

J020199CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER

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

12100B-07640183760037On the market directSTIM 12-electrode leadB-07640183760013On the market directSTIM 24-channel Implantable Pulse GeneratorB-07640183760020On the market directSTIM Adjustable HarnessB-07640183760112On the market directSTIM Charging PaddleB-07640183760105On 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.