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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

HTS-EM2 — Class I MDR by HOSPITAL TECHNICAL…

MD Atlas
HOSPITAL TECHNICAL SOLUTIONS SRL

EUDAMED last updated this device on Apr 4, 2023

HTS-EM2

59447572Etajera4D

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HOSPITAL TECHNICAL SOLUTIONS SRL
UDI-DI code: 05944757200366
Reference / catalog number: HTS-EM2

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View device family (Basic UDI)

Manufacturer information

Organization name: HOSPITAL TECHNICAL SOLUTIONS SRL
SRN: RO-MF-000000925
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	Aug 18, 2021	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 05944757200366
Basic UDI-DI: 59447572Etajera4D
Reference / catalog number: HTS-EM2
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: Monitor shelf with drawer, fixed on the eurorail bar
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05944757200366

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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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.