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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

AMALTHEA COUCH — Class I MDR by FISIOTECH srl

MD Atlas
FISIOTECH srl

EUDAMED last updated this device on May 20, 2024

AMALTHEA COUCH

8050593941111HSJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FISIOTECH srl
UDI-DI code: 80505939405132
Reference / catalog number: 1111H

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View device family (Basic UDI)

Manufacturer information

Organization name: FISIOTECH srl
SRN: IT-MF-000028185
Manufacturer status: Active

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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.

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.
CW257
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: AMALTHEA COUCH
UDI-DI code: 80505939405132
Basic UDI-DI: 8050593941111HSJ
Reference / catalog number: 1111H
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: Lettino a tre segmenti regolabile idraulicamente in altezza da cm. 56 a cm. 96 mediante comando a pedale, pedaliera circolare. Testata regolabile mediante pistone a gas. Foro per la respirazione completo di tappo. Il piano imbottito e rivestito in similpelle lavabile ed ignifugo classe 1 IM. Portata max 200 Kg. uniformemente distribuiti.
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)80505939405132

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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.

Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - 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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