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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

AMT0381CH — Class IIa MDR by Produtos Médicos…

MD Atlas
Produtos Médicos Hospitalares, SA

EUDAMED last updated this device on Apr 27, 2026

AMT0381CH

56077161007U

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Produtos Médicos Hospitalares, SA
UDI-DI code: 05607716103831
Reference / catalog number: AMT0381CH

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Manufacturer information

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

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: 05607716103831
Basic UDI-DI: 56077161007U
Reference / catalog number: AMT0381CH
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: TIVA SET CH01
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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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.