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Organization name
UDI-DI code
Reference / catalog number

4065333051477 — Class IIa MDR by MedTec Medizintechnik…

MD Atlas
MedTec Medizintechnik GmbH

EUDAMED last updated this device on Mar 27, 2024

4065333051477

40653330MBSTJR

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MedTec Medizintechnik GmbH
UDI-DI code: 04065333051477
Reference / catalog number: 4065333051477

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Manufacturer information

Organization name: MedTec Medizintechnik GmbH
SRN: DE-MF-000009592
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

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		Still on market
Spain		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04065333051477
Basic UDI-DI: 40653330MBSTJR
Reference / catalog number: 4065333051477
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: MBST Magnetic Resonance therapy devices are used for the treatment of indications and types of tissue for afflictions, injuries and painful, degenerative and/or pathological changes of the musculoskeletal system. The MBST® OSTEO·SPIN 2 magnetic resonance therapy system is a large-volume system with a double Helmholtz coil system. The system can be opened upwards for access to the couch. The actual treatment unit of the MBST® OSTEO·SPIN 2 therapy system consists of two applicators with a sweep coil each that are located to the left and right side of the treatment couch as well as one RF coil arranged under the cushion and another RF coil vertically above the cushion. In their activated state, the applicators generate a DC magnetic field, which is superimposed by an alternating electromagnetic field in such a way that the specific waveform of the alternating field generates magnetic resonance in the treated area of tissue of the patient. Due to its construction, the therapy device is intended for whole-body treatment.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11059099VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – 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

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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.