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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

AMT056-0095O — Class IIa MDR by Produtos Médicos…

MD Atlas
Produtos Médicos Hospitalares, SA

EUDAMED last updated this device on Apr 27, 2026

AMT056-0095O

56077161007U

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Produtos Médicos Hospitalares, SA
UDI-DI code: 05607716102223
Reference / catalog number: AMT056-0095O

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View device family (Basic UDI)

Manufacturer information

Organization name: Produtos Médicos Hospitalares, SA
SRN: PT-MF-000007631
Manufacturer status: Active

Related devices

301.5061560771630086On the market 307.5052560771630086On the market 310.5047560771630086On the market 307.5048560771630086On the market 310.5046560771630086On 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.

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Portugal; available across 2 countries total.

Country	On market since	Until
PortugalPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05607716102223
Basic UDI-DI: 56077161007U
Reference / catalog number: AMT056-0095O
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: INFUSION SYSTEM SAFETYMIT RV 300cm ORAGE
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

EMDN nomenclature code(s)

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

A03010103INFUSION CONTROLLERS WITH FLOW REGULATOR

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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