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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

SPHP E — Class IIa MDR by BMT Medical Technology…

MD Atlas
BMT Medical Technology s.r.o.

EUDAMED last updated this device on Jun 16, 2023

SPHP E

859420341SPHPLU

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BMT Medical Technology s.r.o.
UDI-DI code: 08594203410015
Reference / catalog number: SPHP E

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Manufacturer information

Organization name: BMT Medical Technology s.r.o.
SRN: CZ-MF-000001680
Manufacturer status: Active

Related devices

SPHPSB-08594203410503On the market SPHP S859420341SPHPLUOn the market StericellB-08594203410084On the market STERICELL859420341SCXSOn the market SPHPEB-08594203410015On 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.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Jun 20, 2016	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594203410015
Basic UDI-DI: 859420341SPHPLU
Reference / catalog number: SPHP E
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: steam sterilizer
Additional information URL: https://www.bmt.cz/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011380CLEANING, DISINFECTION AND STERILISATION 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

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Expiration date
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