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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

E100100 — Class IIa MDR by Elosan AG

MD Atlas
Elosan AG

EUDAMED last updated this device on Sep 13, 2022

E100100

7649990911100100VY

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Elosan AG
UDI-DI code: 07649990911014
Reference / catalog number: E100100

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Manufacturer information

Organization name: Elosan AG
SRN: CH-MF-000027539
Manufacturer status: Active

Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Sep 13, 2022	Sep 13, 2032
Liechtenstein	Sep 13, 2022	Sep 13, 2032

Device identification

Trade name: not provided
UDI-DI code: 07649990911014
Basic UDI-DI: 7649990911100100VY
Reference / catalog number: E100100
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Die Elosan Kabine C1 ist eine geschlossene, elektrisch isolierte Kabine zur Ganzkörper-Schmerztherapie durch Elektrostatik. Eine leitende Beschichtung steuert das elektrische Feld, welches durch ein Hochspannungsmodul mit 50'000 Volt erzeugt wird. Über einen Handgriff wird die elektrostatische Ladung auf den Patienten geleitet und gleichmässig auf die gesamte Körperoberfläche verteilt. Nach der Behandlung ist der Patient wieder vollständig entladen und geerdet.
Additional information URL: https://www.elosan.com/de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120601ELECTROTHERAPY EQUIPMENT (INCLUDED TENS)

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

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

HZ 1231626-1refdata.certificate-status.cancelled
Quality management systemNotified body: 0197Expiry: Jan 28, 2030