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Organization name
UDI-DI code
Reference / catalog number

TeslaiV1 — Class I MDR by MIPM Mammendorfer…

MD Atlas
MIPM Mammendorfer Institut für Physik und Medizin GmbH

EUDAMED last updated this device on Mar 3, 2025

TeslaiV1

42556292001011LS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MIPM Mammendorfer Institut für Physik und Medizin GmbH
UDI-DI code: 04255629200249
Reference / catalog number: 1190001

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Manufacturer information

Organization name: MIPM Mammendorfer Institut für Physik und Medizin GmbH
SRN: DE-MF-000007654
Manufacturer status: Active

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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.

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: TeslaiV1
UDI-DI code: 04255629200249
Basic UDI-DI: 42556292001011LS
Reference / catalog number: 1190001
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The TeslaiV1 is an MRI system rack for the operation of one single B. Braun Spaceplus Infusion Pump (Perfusor® or Infusomat®) during MRI examinations (MRI procedures). The TeslaiV1 does not control the operation of the installed infusion pump. The TeslaiV1 is a RF-shielded housing which can optionally mounted on a trolley or attached to an infusion pole. The construction of the housing makes it possible to position the system within the MR environment; it provides a shielded space for one single B. Braun Spaceplus Infusion Pump (Perfusor® or Infusomat®). A window allows for direct viewing of the inserted infusion pump, allowing all pump status and alarm conditions to be observed. The TeslaiV1 provides Infusion Line Guide inlets and outlets. The Spaceplus Infusion Pump (Perfusor® or Infusomat®) can only be installed and removed by authorized service personnel. The TeslaiV1 is MR conditional and intended to be used in the MR environment. The TeslaiV1 contains a Magnetic Field Indicator (MFI) which measures the magnetic field and serves as a positioning support for the trained user to position the TeslaiV1 on its released magnetic field strength. If the released magnetic field strength is exceeded, the trained user is notified in advance via optical and acoustic signals before damage to the devices occur. The TeslaiV1 is not connected to any network.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030306INFUSION AND SYRINGE PUMP CONTROL 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

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