Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

12100 — AIMDD AIMDD by Aleva Neurotherapeutics…

MD Atlas
Aleva Neurotherapeutics SA

EUDAMED last updated this device on Nov 18, 2021

12100

B-07640183760037

On the marketAIMDD

Applicable legislation: AIMDD [Directive 90/385/EEC on active implantable medical devices]
Organization name: Aleva Neurotherapeutics SA
UDI-DI code: 07640183760037
Reference / catalog number: 12100

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
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: not provided
UDI-DI code: 07640183760037
Basic UDI-DI: B-07640183760037
Reference / catalog number: 12100
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)

J020102DEEP BRAIN STIMULATION (DBS) LEADS

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

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 directSTIM Clinician ProgrammerB-07640183760044On 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.