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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

SMTHW200 — Class I MDR by SMT Service-Medizin-Tech…

MD Atlas
SMT Service-Medizin-Technik GmbH

EUDAMED last updated this device on Jul 6, 2023

SMTHW200

426241036SMTHW200SU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SMT Service-Medizin-Technik GmbH
UDI-DI code: 04262410360013
Reference / catalog number: SMTHW200

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Manufacturer information

Organization name: SMT Service-Medizin-Technik GmbH
SRN: DE-MF-000025990
Manufacturer status: Active

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: 04262410360013
Basic UDI-DI: 426241036SMTHW200SU
Reference / catalog number: SMTHW200
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: Der MIVONA Signalprozessor ist ein Zubehör der Softwarelösung MIVONA KRS-MANAGER und dient zur Dokumentationsunterstützung im klinischen Umfeld. Insbesondere ermöglicht der Signalprozessor, die Biosignale von Vitalmonitoren (Hardware) aufzunehmen und über eine definierte Standardschnittstelle einem Darstellungsclient, dem MIVONA KRS Manger, zur Verfügung zu stellen. Des Weiteren konvertiert der Signalprozessor die aufgenommen Biosignale in ein für die digitale Dokumentation übliches Format (PDF) und überträgt sie über eine HL7-Schnittstelle in ein Archiv.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12080180PRENATAL DIAGNOSTIC INSTRUMENTS - HARDWARE ACCESSORIES

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

SMTHW500426241036SMTSW500X4On 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.