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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

301510 — Class IIa MDD by SAVIR GmbH

MD Atlas
SAVIR GmbH

EUDAMED last updated this device on Oct 28, 2021

301510

B-SASmRH

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SAVIR GmbH
UDI-DI code: D-SASmRH
Reference / catalog number: 301510

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Manufacturer information

Organization name: SAVIR GmbH
SRN: DE-MF-000007028
Manufacturer status: Active

Critical warnings

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

CW014
Grenzwert für Patientenableitstrom; muss von Erde getrennt aufgebaut werden
CW147
Jeglichen Kontakt von Flüssigkeiten mit dem Gerät vermeiden

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 27, 2021	May 27, 2024

Device identification

Trade name: not provided
UDI-DI code: D-SASmRH
Basic UDI-DI: B-SASmRH
Reference / catalog number: 301510
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Stimulator zur kranialen Elektrotherapie
Additional information URL: No additional information URL provided by the manufacturer.
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

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.